1. What Is the FDA?

The U.S. Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services (HHS). Its mission is to protect and promote public health by regulating a broad range of products that can affect human health and safety. These include human and veterinary drugs, biological products, medical devices, food, cosmetics, tobacco products, and certain products that emit radiation.

The FDA is therefore not simply an authority that “approves products.” Its responsibilities cover different types of regulatory activities, including evaluating products before they can be marketed, establishing regulatory requirements, inspecting facilities, monitoring products after they reach the market, and taking enforcement action when companies or products do not comply with applicable requirements.

For manufacturers of medical devices, the FDA plays a central role in determining whether and under which conditions a device may legally be marketed in the United States.

The FDA and Medical Devices

Medical devices are primarily regulated within the FDA by the Center for Devices and Radiological Health (CDRH). CDRH is responsible for regulating firms that manufacture, repackage, relabel, or import medical devices marketed in the United States.

Its responsibilities cover the entire product lifecycle. This includes activities before a device reaches the U.S. market as well as regulatory oversight after commercialization. CDRH evaluates certain devices and premarket submissions, oversees establishment registration and device listing, conducts inspections, monitors adverse events and recalls, and takes compliance and enforcement actions when necessary.

This is an important distinction: FDA compliance does not end when a device receives marketing authorization. Depending on the device and its regulatory status, manufacturers may continue to have obligations concerning quality systems, labeling, reporting, registration, listing, post-market surveillance, and other regulatory controls.

Why Does the FDA Exist?

The fundamental purpose of FDA regulation is to protect patients, healthcare professionals, and consumers from products that could present unacceptable risks while supporting access to safe and effective innovations.

For medical devices, CDRH describes its mission as assuring that patients and providers have access to safe, effective, and high-quality medical devices, while also supporting medical-device innovation and maintaining public confidence in devices marketed in the United States.

FDA regulation is therefore based on a risk-oriented approach. Not every medical device is subject to the same regulatory pathway or level of scrutiny. The regulatory requirements depend, among other factors, on the device’s intended use, characteristics, and potential risk. FDA classifies medical devices into Class I, Class II, and Class III, with increasing regulatory controls as the potential risk increases.

This risk-based structure is one of the most important concepts to understand before attempting to enter the U.S. market.

A manufacturer should therefore not begin with the question:

“How do I get FDA approval?”

The more appropriate starting question is:

“How is my medical device regulated by the FDA, and what regulatory pathway applies to it?”

Depending on the product, a manufacturer may need a premarket submission such as a 510(k), De Novo request, or Premarket Approval (PMA). Some devices are exempt from certain premarket submission requirements. In addition, all applicable regulatory controls must be addressed even when no premarket submission is required.

The following chapters explain how to determine which situation applies to a particular medical device and what a manufacturer needs to do before and after placing the product on the U.S. market.

Official FDA resources

• FDA – What We Do
• FDA – Center for Devices and Radiological Health (CDRH)
• FDA – Overview of Device Regulation
• FDA – How to Study and Market Your Device

2. Why Does the FDA Regulate Medical Devices?

Medical devices can have a direct impact on a patient’s health, diagnosis, treatment, or safety. A device may be as simple as a manual instrument or as complex as an implantable, software-controlled, or life-supporting system. Because the consequences of a device malfunction, incorrect use, or misleading claim can be significant, the U.S. regulatory framework is designed to provide reasonable assurance that medical devices marketed in the United States are safe and effective for their intended use.

The FDA does not regulate every device in exactly the same way. Instead, the regulatory system is largely risk-based. The level of regulatory control is determined by the nature of the device and the risks associated with its intended use. The FDA classifies devices as Class I, Class II, or Class III, with the regulatory controls generally increasing with the level of risk.

Protecting Patients and Users

The primary reason for FDA regulation is to protect patients and users from unreasonable risks while ensuring that devices perform as intended.

Potential risks can arise from many different sources. A device may:

• produce an incorrect diagnostic result;
• fail to perform its intended function;
• expose a patient to excessive energy or radiation;
• contain a software or cybersecurity vulnerability;
• cause injury because of a mechanical or electrical failure;
• be incorrectly labeled or supplied with inadequate instructions for use; or
• create risks that were not adequately addressed during design and manufacturing.

FDA regulation therefore goes beyond checking whether a finished product works. Depending on the device, regulatory controls can address its design, manufacturing, labeling, performance, clinical evidence, and post-market monitoring.

Why Risk Classification Matters

A low-risk device does not necessarily require the same level of regulatory evidence as a high-risk implantable device. Applying identical requirements to every device would create unnecessary regulatory burden for low-risk products while failing to focus resources where the potential consequences are greatest.

The FDA therefore uses different levels of regulatory control. Some Class I devices are exempt from certain premarket submission requirements, while many Class II devices require a 510(k) submission. Class III devices generally require Premarket Approval (PMA) unless another specific regulatory pathway applies.

This means that the regulatory process cannot be determined simply from the fact that a product is called a “medical device.” The manufacturer must first understand what the device is, what it is intended to do, and how the FDA classifies it.

Regulation Before and After Market Entry

FDA oversight is not limited to the point at which a device enters the U.S. market.

Before marketing, the FDA may require evidence demonstrating that the device meets the applicable requirements for its regulatory pathway. Depending on the device, this can involve performance testing, comparison with an existing legally marketed device, clinical evidence, risk-related information, labeling, or other documentation.

After market entry, manufacturers may remain subject to requirements such as establishment registration and device listing, quality-system requirements, medical device reporting, corrections and removals, and other post-market obligations. FDA’s registration and listing system itself explicitly distinguishes registration and listing from FDA approval: registration or listing does not mean that FDA has approved the establishment or the product.

The result is a lifecycle-based regulatory system rather than a single approval event.

The Practical Consequence for Manufacturers

For a manufacturer planning to enter the U.S. market, FDA compliance should therefore not be treated as a final administrative step.

The regulatory strategy should be considered during product development, because decisions about the intended use, design, technology, labeling, testing, and manufacturing can directly affect the applicable regulatory requirements.

The first practical question is consequently not:

“Which FDA form do I need to submit?”

It is:

“What exactly is my device, how is it classified, and what regulatory controls apply to it?”

The next chapter addresses this starting point: determining whether a product is regulated as a medical device and establishing the product classification that forms the basis for the subsequent FDA pathway.

Official FDA sources

• FDA – How to Determine if Your Product is a Medical Device
• FDA – Device Classification Panels
• FDA – Device Registration and Listing

3. Is Your Product a Medical Device?

Before a manufacturer can determine the appropriate FDA regulatory pathway, it must first establish whether its product is legally considered a medical device under U.S. law.

This question is more important than it may initially appear.

A product can be used in a healthcare environment without necessarily being a medical device. Conversely, a product that looks like a consumer or electronic product may fall under the FDA’s medical-device regulations if its intended use meets the applicable legal definition.

The classification therefore does not depend solely on what the product looks like or where it is sold.

The starting point is the intended use and intended purpose of the product.

3.1 The FDA Definition of a Medical Device

The legal definition of a medical device is found in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In simplified terms, a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar article that is:

• recognized in the U.S. National Formulary, the United States Pharmacopeia, or an official compendium;
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or
• intended to affect the structure or any function of the body,

and which does not achieve its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized to achieve its primary intended purposes.

This distinction is important because the FDA regulates many different types of healthcare-related products, but they do not all fall under the medical-device framework.

The FDA therefore looks at the legal characteristics and intended use of the product, not simply at whether the product is associated with healthcare.

FDA – Is It a Medical Device?

3.2 Intended Use Is the Starting Point

One of the most important concepts in FDA medical-device regulation is Intended Use.

The FDA does not determine whether a product is a medical device solely from its technical design.

The intended purpose of the product is fundamental.

For example, an electronic sensor could potentially be:

• a general-purpose consumer sensor;
• an industrial measurement device;
• a wellness product; or
• a medical device.

The underlying technology could be very similar in each case.

What changes is what the manufacturer intends the product to do and what claims are made about its use.

This is why the following elements need to be considered carefully:

• product labeling;
• Instructions for Use;
• product descriptions;
• website content;
• marketing material;
• advertising;
• technical documentation;
• claims made to customers.

A manufacturer cannot necessarily avoid FDA medical-device regulation simply by avoiding the words medical device if the actual intended use and claims place the product within the statutory definition.

3.3 Medical Purpose Alone Does Not Answer Every Regulatory Question

The fact that a product has a medical purpose does not automatically tell the manufacturer which FDA requirements apply.

Once a product has been identified as a medical device, additional questions must be answered:

1. What type of medical device is it?
2. What is its FDA classification?
3. What Product Code applies?
4. Is there a legally marketed predicate device?
5. Which regulatory pathway is appropriate?
6. What testing and evidence are required?
7. Does the device require FDA clearance, approval, or another form of authorization before marketing?

The determination that a product is a medical device is therefore only the starting point of the regulatory assessment.

3.4 Examples of Products That Can Be Medical Devices

The FDA regulates a very broad range of medical devices.

Depending on their intended use, examples can include:

• diagnostic equipment;
• patient monitoring equipment;
• infusion pumps;
• ventilators;
• surgical instruments;
• implants;
• medical imaging equipment;
• laboratory diagnostic devices;
• wearable medical devices;
• software used for medical purposes;
• connected or wireless medical devices;
• medical sensors;
• certain medical accessories.

The technology itself does not determine the regulatory status.

For example, a product containing Bluetooth, Wi-Fi, cellular connectivity, or another radio technology can still be a medical device if its intended use falls within the FDA definition.

The presence of wireless technology therefore does not remove the product from FDA regulation.

3.5 Medical Device Software

Software requires particular attention because a medical device does not have to be a physical piece of hardware.

Software can itself fall within the FDA’s medical-device framework when it meets the applicable definition.

Examples can include software intended to:

• diagnose a disease or condition;
• assist in diagnosis;
• monitor a patient’s condition;
• analyze medical information for a medical purpose;
• control or influence the operation of a medical device;
• provide information used for diagnosis or treatment.

At the same time, not all health-related software is regulated as a medical device.

The FDA has specific policies and statutory provisions concerning certain software functions and categories.

Manufacturers should therefore assess the specific function and intended use of the software, rather than assuming that every health-related application is either regulated or exempt.

3.6 Medical Device vs. General Consumer Product

A particularly important distinction is between a medical device and a general consumer product.

Consider two products that both measure heart rate.

Product A

The manufacturer markets it as a general fitness product and uses the information to support exercise tracking.

Product B

The manufacturer claims that it monitors patients and detects or supports the diagnosis of a specific cardiac condition.

Although the underlying sensing technology could be similar, the regulatory implications can be very different.

The manufacturer’s claims and intended use can therefore have a direct impact on whether FDA medical-device requirements apply.

This is one reason why regulatory assessment should begin before product claims and marketing material are finalized.

3.7 Medical Device vs. Drug

The FDA also regulates drugs, and the distinction between a medical device and a drug can sometimes be important.

A product whose primary intended purpose is achieved through chemical action within or on the body, or that depends on being metabolized to achieve its primary intended purpose, may fall under the drug framework rather than the medical-device definition.

Some products can also involve characteristics of more than one regulatory category.

These products may require a specific regulatory determination concerning which FDA Center and regulatory framework applies.

Manufacturers should therefore not attempt to determine the regulatory category solely from the product name or commercial description.

3.8 Combination Products

Some products combine characteristics of different FDA-regulated product types.

These are known as combination products.

A combination product can, for example, combine:

• a drug and a device;
• a device and a biological product;
• a drug, device, and biological product.

The regulatory pathway for such products can be more complex because more than one regulatory framework may be involved.

The FDA’s Office of Combination Products (OCP) helps determine which FDA Center has primary jurisdiction over combination products and coordinates regulatory policy concerning them.

For a manufacturer, this means that a product should be assessed carefully if it combines characteristics of a medical device with a drug or biological product.

FDA – Office of Combination Products

3.9 Products Used in Healthcare Are Not Automatically Medical Devices

A common misconception is:

“If a product is used in a hospital, it must be an FDA medical device.”

That is not necessarily correct.

Hospitals use a very broad range of products, including:

• furniture;
• general IT equipment;
• communication systems;
• cleaning products;
• general-purpose electronics;
• administrative software;
• medical devices;
• drugs;
• biological products.

The environment in which a product is used does not by itself determine its FDA regulatory status.

The intended use and applicable statutory definition remain the starting point.

3.10 The Role of Product Claims

Manufacturers should pay particular attention to claims because claims can influence the regulatory interpretation of a product.

Relevant claims can appear in many places:

• product packaging;
• Instructions for Use;
• website;
• brochures;
• technical datasheets;
• advertising;
• sales presentations;
• user interfaces;
• online stores;
• social media.

A manufacturer may therefore have a product that technically could be positioned in a non-medical context, but whose marketing claims create a medical intended use.

For regulatory purposes, it is therefore important that the technical product definition, intended use, labeling and marketing claims are aligned.

3.11 What If You Are Unsure?

Manufacturers sometimes face products for which the regulatory status is not obvious.

In such cases, the FDA provides mechanisms for obtaining additional regulatory feedback.

Depending on the specific question, manufacturers may consider:

• reviewing FDA guidance;
• examining similar devices and their classifications;
• identifying applicable Product Codes;
• reviewing FDA databases;
• contacting the relevant FDA Center;
• requesting a formal classification or regulatory determination where an appropriate mechanism exists.

The FDA’s Device Classification resources can be particularly useful when determining how similar products are regulated.

FDA – Device Classification

3.12 A Practical Decision Process

For a manufacturer, the initial assessment can be structured into a simple sequence:

Step 1 – Define the Product

What exactly is the product?

• Hardware?
• Software?
• Combination of hardware and software?
• Accessory?
• Component?
• Combination product?

Step 2 – Define the Intended Use

What is the manufacturer intending the product to do?

Step 3 – Review the Claims

What does the manufacturer actually tell customers the product does?

Step 4 – Apply the FDA Definition

Does the intended use fall within the statutory definition of a medical device?

Step 5 – Determine the Device Classification

If it is a medical device:

• What is the device classification?
• What Product Code applies?
• What regulation applies?

Step 6 – Identify the Regulatory Pathway

Only after these questions have been addressed should the manufacturer determine whether the product requires:

• 510(k) clearance;
• De Novo classification;
• PMA approval;
• another applicable pathway; or
• potentially no premarket submission under the circumstances.

3.13 Why This Assessment Should Happen Early

The classification of a product as a medical device can affect almost every subsequent regulatory decision.

It can influence:

• applicable FDA regulations;
• Product Code;
• device classification;
• Regulatory Pathway;
• testing requirements;
• clinical evidence;
• labeling;
• Quality Management System requirements;
• registration and listing;
• UDI obligations;
• post-market obligations;
• project cost and timeline.

A manufacturer that makes this determination too late can therefore discover that fundamental aspects of the product or its documentation need to be changed.

The best approach is to establish the regulatory status before significant testing, documentation and marketing decisions are finalized.

3.14 The Key Takeaway

The first FDA question is not:

“Which FDA form do we need to submit?”

It is:

“Is our product a medical device under U.S. law, and if so, how is it classified?”

Only after that question has been answered can the appropriate Regulatory Pathway and evidence strategy be established.

For ScopeRight, this distinction is particularly important because the regulatory assessment should begin with the product and its intended use, not with a predefined list of FDA forms or tests.

Once a product has been established as a medical device, the next step is to determine its FDA classification and the appropriate regulatory pathway.

4. FDA Medical Device Classification: Class I, Class II and Class III

Once a product has been identified as a medical device and its intended use has been established, the next question is its FDA device classification.

The FDA uses a risk-based classification system with three classes: Class I, Class II, and Class III. The class determines the level of regulatory control required to provide reasonable assurance of the device’s safety and effectiveness. As the class increases, the level of regulatory control generally becomes more stringent.

It is important to understand that the class is not simply a general statement that a product is “low,” “medium,” or “high” risk. Classification is based on the device’s intended use, indications for use, technological characteristics, and the regulatory controls considered necessary for that particular device type.

Class I – General Controls

Class I represents the least stringent regulatory class. These devices are considered sufficiently controlled through General Controls.

General Controls are the baseline requirements established under the Federal Food, Drug, and Cosmetic Act. They apply to medical devices across all three classes unless a specific exemption applies. Examples include requirements concerning:

• establishment registration;
• device listing;
• labeling;
• records and reports;
• medical device reporting;
• manufacturing and quality requirements; and
• preventing adulteration and misbranding.

Many Class I devices are exempt from the 510(k) premarket notification requirement. However, Class I does not automatically mean “no FDA requirements.” Exemptions have specific limitations, and the applicable regulation must be checked for the individual device.

Class II – General Controls and Special Controls

Class II devices require more regulatory control than Class I devices.

For these products, General Controls alone are not considered sufficient to provide reasonable assurance of safety and effectiveness. The FDA therefore uses Special Controls in addition to the General Controls.

Special Controls are generally device-specific and can include:

• performance standards;
• specific performance or laboratory testing;
• special labeling requirements;
• post-market surveillance;
• patient registries; or
• other measures addressing particular risks associated with the device.

Many Class II devices require a 510(k) Premarket Notification before they can be marketed in the United States. However, some Class II devices are exempt from 510(k), subject to the limitations of their exemption.

Class III – General Controls and Premarket Approval

Class III is the highest FDA device classification.

These devices generally present the highest level of potential risk, or there is insufficient information to establish that General Controls and Special Controls are sufficient to provide reasonable assurance of safety and effectiveness. Class III devices are therefore generally subject to Premarket Approval (PMA).

PMA is substantially different from a 510(k). The FDA describes PMA as its process for the scientific and regulatory review of Class III devices to determine whether there is reasonable assurance of their safety and effectiveness.

The Classification Determines the Regulatory Path

The relationship can be summarized as follows:

Device class	Main regulatory controls	Typical premarket situation
Class I	General Controls	Many devices exempt from 510(k)
Class II	General Controls + Special Controls	Many require 510(k)
Class III	General Controls + PMA	Generally requires PMA

This table describes the general framework, not an automatic rule for every individual device. Specific regulations and exemptions must always be checked.

This is why identifying the correct product code and classification regulation is so important. The classification determines the regulatory controls and strongly influences which premarket pathway the manufacturer must follow.

Classification Does Not Mean the Product Is “Approved”

A common misunderstanding is that being classified as Class I or Class II means that the FDA has approved the individual product.

It does not.

Classification is a regulatory category. It determines the controls and, where applicable, the type of premarket submission required. A device can be Class II, for example, while still requiring a 510(k) submission and FDA clearance before it can legally be marketed.

Likewise, registration and device listing are separate from FDA clearance or approval. These concepts should not be confused.

The next step is therefore to determine which market-access pathway applies to the classified device. Depending on the product, this may involve a 510(k), De Novo classification, PMA, or an exemption.

Official FDA sources

• FDA – Classify Your Medical Device
• FDA – Regulatory Controls
• FDA – General Controls for Medical Devices
• FDA – How to Study and Market Your Device

5. Choosing the Right FDA Regulatory Pathway

Once a product has been determined to be a medical device, the next question is:

What FDA regulatory pathway applies to this device?

This is one of the most important decisions in the entire U.S. market-access process.

The FDA does not use a single approval procedure for all medical devices. The appropriate pathway depends on factors such as the device’s classification, intended use, risk, technology, applicable regulation, and whether a comparable legally marketed device already exists.

Choosing the wrong pathway can result in unnecessary testing, additional costs, delays, or a submission that cannot be accepted in its proposed form.

The main premarket pathways relevant to medical devices are:

• 510(k) Premarket Notification
• De Novo Classification Request
• Premarket Approval (PMA)

There are also devices that are exempt from premarket submission requirements under specific FDA regulations.

5.1 The Regulatory Pathway Starts With Classification

The regulatory pathway should not be selected simply because a particular procedure appears easier or faster.

The starting point is the FDA device classification.

Medical devices are generally classified into three classes:

Class	General risk level	Typical regulatory approach
Class I	Lower risk	Often subject to general controls; many are exempt from 510(k)
Class II	Moderate risk	Generally subject to general and special controls; many require 510(k)
Class III	Higher risk	Generally subject to general controls and PMA

This is a general framework rather than an automatic rule for every individual product.

For example, not every Class II device necessarily requires a 510(k), and some Class I and Class II devices are exempt from premarket notification.

The applicable device regulation and Product Code therefore need to be identified before selecting the pathway.

FDA – Device Classification

5.2 The Main FDA Pathways

For most manufacturers, the decision can be simplified initially into four questions:

Is the device exempt from premarket submission?

If not:

Is there an appropriate legally marketed predicate device?

→ 510(k) may be appropriate.

If there is no suitable predicate:

Could the device be classified through the De Novo pathway?

→ De Novo may be appropriate.

If the device is a high-risk Class III device requiring the highest level of premarket assurance:

→ PMA may be required.

This can be represented as:

Medical Device
↓
Determine Classification / Product Code
↓
Premarket submission exempt?
→ Yes → No Premarket Submission under that exemption
→ No ↓
Appropriate Predicate Device?
→ Yes → 510(k)
→ No ↓
Eligible for De Novo?
→ Yes → De Novo
→ No → PMA or another applicable pathway

This is a simplified decision model. The actual regulatory assessment must always consider the specific device and applicable FDA requirements.

5.3 510(k) Premarket Notification

The 510(k) is one of the most commonly used FDA pathways for medical devices.

A manufacturer submits a Premarket Notification to demonstrate that its device is substantially equivalent to a legally marketed predicate device.

This does not mean that the new device must be identical to the predicate.

A new device can differ from the predicate in areas such as:

• design;
• materials;
• technology;
• components;
• software;
• indications;
• dimensions;
• performance characteristics.

The important question is whether the differences affect the device’s safety and effectiveness in a way that prevents a finding of substantial equivalence.

5.4 What Is a Predicate Device?

A predicate device is generally a legally marketed device to which the new device can be compared for purposes of the 510(k) substantial-equivalence determination.

The predicate is therefore one of the most important elements of a 510(k) strategy.

A manufacturer should not simply choose a device that looks similar.

The predicate should be appropriate considering factors such as:

• intended use;
• technological characteristics;
• indications;
• performance;
• applicable risks;
• regulatory classification.

FDA databases can be used to identify devices that have previously been cleared.

However:

Finding a similar device in an FDA database does not automatically mean that it is an appropriate predicate.

The manufacturer must establish the regulatory and technical relevance of the comparison.

5.5 Substantial Equivalence

The central question in a traditional 510(k) is whether the new device is substantially equivalent to the predicate.

In general, FDA considers whether the device:

1. has the same intended use as the predicate; and
2. has the same technological characteristics as the predicate;

or whether any differences in technological characteristics:

• do not raise different questions of safety and effectiveness; and
• demonstrate that the device is at least as safe and effective as the predicate.

Therefore, substantial equivalence does not mean identical.

A device can incorporate new technology and still potentially be cleared through 510(k), provided the statutory criteria are satisfied.

FDA – Premarket Notification 510(k)

5.6 Different Types of 510(k)

The FDA recognizes several 510(k) submission formats.

The main types include:

Traditional 510(k)

The conventional pathway used for many devices.

The manufacturer submits the required information and FDA evaluates whether substantial equivalence has been demonstrated.

Special 510(k)

A Special 510(k) can be used for certain device modifications where the manufacturer can rely on appropriate design-control procedures and other applicable criteria.

It is particularly relevant when a manufacturer is modifying its own legally marketed device.

Abbreviated 510(k)

An Abbreviated 510(k) can rely, where applicable, on:

• FDA guidance documents;
• special controls; or
• recognized consensus standards.

The appropriate format depends on the device and the circumstances of the submission.

5.7 When 510(k) Is Not Appropriate

A 510(k) is not simply the default application for every Class II device.

A 510(k) requires an appropriate predicate.

If no suitable predicate exists, the manufacturer may need to consider another pathway.

This is where the De Novo pathway can become important.

5.8 The De Novo Classification Pathway

The De Novo Classification Request provides a pathway for certain novel devices for which there is no suitable predicate device.

It was designed for devices that present low to moderate risk and for which classification into Class I or Class II, with appropriate controls, is sufficient to provide reasonable assurance of safety and effectiveness.

The De Novo pathway is therefore fundamentally different from a PMA.

The manufacturer is not simply asking the FDA to approve a high-risk device.

Instead, the manufacturer is asking the FDA to establish an appropriate classification for a new type of device.

If granted, the De Novo device can become a predicate device for future 510(k) submissions.

FDA – De Novo Classification Requests

5.9 When Is De Novo Appropriate?

A De Novo request can be relevant where:

• the device is novel;
• there is no suitable predicate;
• the device is not appropriate for Class I or Class II through an existing classification;
• the risks can be adequately controlled through general and/or special controls.

The manufacturer therefore needs to demonstrate that the device can be regulated at a level below PMA.

The De Novo pathway should not be understood simply as:

“There is no predicate, so we automatically use De Novo.”

The manufacturer must establish that the device meets the statutory requirements for De Novo classification.

5.10 What Happens After a De Novo Grant?

If FDA grants the De Novo request, the device is classified, generally as Class I or Class II.

The FDA can also establish special controls where appropriate.

An important consequence is that a granted De Novo device can subsequently serve as a predicate for future 510(k) submissions.

This creates an important regulatory sequence:

Novel Device
↓
De Novo
↓
Class I / Class II Classification
↓
Future Similar Devices
↓
510(k) Using the De Novo Device as Predicate

For innovative technologies, this can therefore have long-term regulatory significance beyond the original product.

5.11 Premarket Approval (PMA)

Premarket Approval (PMA) is the FDA’s most stringent premarket pathway for medical devices.

It is generally associated with Class III devices, where general and special controls are not sufficient to provide reasonable assurance of safety and effectiveness.

A PMA requires substantial scientific evidence demonstrating that the device is safe and effective for its intended use.

Depending on the device, the submission can involve extensive:

• non-clinical testing;
• clinical data;
• manufacturing information;
• risk information;
• labeling;
• design information;
• performance data.

The PMA process is therefore generally considerably more demanding than a 510(k).

FDA – Premarket Approval (PMA)

5.12 510(k) vs. De Novo vs. PMA

The three main pathways can be summarized as follows:

	510(k)	De Novo	PMA
Main purpose	Demonstrate substantial equivalence	Classify a novel device	Demonstrate safety and effectiveness
Predicate required?	Yes	No	No
Typical device risk	Low–moderate	Low–moderate	High
Typical class	Class II	Class I or II	Class III
Clinical evidence	Sometimes required	Depending on risk/device	Often significant
Regulatory burden	Moderate	Moderate to high	High
Result	Clearance	Classification	Approval

This table is intentionally simplified. Individual devices can have different requirements.

5.13 Premarket Submission Exemptions

Not every medical device requires a premarket submission.

Some devices are exempt from:

• 510(k) submission; or
• certain other premarket requirements,

subject to the applicable FDA regulations and limitations.

For example, many Class I devices are 510(k)-exempt.

However:

510(k)-exempt does not mean FDA-exempt.

A device can be exempt from premarket notification while remaining subject to other FDA requirements, including applicable:

• general controls;
• Quality System requirements;
• registration and listing;
• labeling requirements;
• Medical Device Reporting;
• complaint handling;
• post-market obligations.

The manufacturer therefore needs to determine the exact scope of the exemption rather than interpreting “exempt” as “not regulated.”

FDA – 510(k) Exemptions

5.14 What If the Manufacturer Is Unsure About the Pathway?

The regulatory pathway should ideally be established before substantial testing and submission preparation begins.

If there is uncertainty, the FDA offers the Q-Submission Program, which includes mechanisms for obtaining FDA feedback before submitting certain marketing applications.

One important mechanism is the Pre-Submission (Pre-Sub).

A Pre-Sub allows a manufacturer to request FDA feedback on specific questions related to its planned regulatory submission.

This can be particularly useful for questions concerning:

• proposed testing;
• study design;
• regulatory strategy;
• clinical evidence;
• predicate selection;
• planned submission content;
• other important issues where FDA feedback could reduce uncertainty.

A Pre-Sub is not an approval of the future device or submission.

Its purpose is to obtain FDA feedback before the formal submission.

FDA – Q-Submission Program

5.15 What Should Be Determined Before Choosing the Pathway?

Before starting the formal FDA submission process, a manufacturer should have a clear understanding of at least the following:

Product

What exactly is being placed on the U.S. market?

Intended Use

What is the device intended to do?

Indications for Use

For whom and under what conditions is it intended to be used?

Classification

What FDA device classification applies?

Product Code

Which FDA Product Code is appropriate?

Predicate

If considering 510(k), which legally marketed device provides the appropriate comparison?

Technology

Are there technological differences from the predicate?

Risk

What risks arise from the device and its technology?

Evidence

What testing, performance data and, where applicable, clinical evidence are needed?

Labeling

What labeling and claims will be used?

Quality System

What manufacturing and quality-system requirements apply?

Only after these questions have been addressed should the manufacturer finalize its regulatory strategy.

5.16 Testing Should Follow the Regulatory Strategy

One of the most common mistakes is to begin testing before the regulatory pathway and applicable FDA requirements have been properly established.

The manufacturer may then discover that:

• the wrong standard was used;
• the wrong test configuration was selected;
• the required performance characteristics were not evaluated;
• additional testing is necessary;
• the selected predicate requires a different comparison;
• clinical evidence is required;
• the test report does not provide the information needed for the submission.

Testing should therefore be derived from the regulatory strategy and submission requirements.

The correct sequence is generally:

Product Definition
↓
Intended Use
↓
Classification / Product Code
↓
Regulatory Pathway
↓
Regulatory Requirements
↓
Test Plan / Evidence Plan
↓
Testing and Documentation
↓
FDA Submission

This is precisely where structured regulatory scoping can reduce unnecessary work and prevent expensive re-testing.

5.17 FDA Fees and Costs

FDA market access can involve several different types of costs.

These should not be confused with one another.

Depending on the pathway and circumstances, costs can include:

• FDA user fees;
• laboratory testing;
• clinical studies;
• consultants;
• regulatory preparation;
• Quality Management System implementation;
• manufacturing preparation;
• submission preparation;
• translation or documentation costs;
• U.S. regulatory representation and other market-entry costs.

FDA user fees are separate from the costs of preparing and supporting the submission.

The applicable FDA fees can also change between fiscal years.

Manufacturers should therefore verify the current FDA fee schedule for the applicable fiscal year rather than relying on an older figure.

FDA – Medical Device User Fee Amendments (MDUFA)

5.18 The Regulatory Pathway Determines the Project

Choosing the FDA pathway is not an administrative formality.

It can fundamentally influence the entire market-access project.

For example:

510(k) may require a strong predicate strategy and substantial-equivalence analysis.

De Novo may require the manufacturer to establish a new classification and appropriate controls for a novel technology.

PMA can require significantly more extensive scientific and clinical evidence.

Therefore, the pathway influences:

• project duration;
• testing requirements;
• clinical strategy;
• documentation;
• engineering activities;
• quality-system preparation;
• regulatory costs;
• submission complexity;
• overall time to market.

A manufacturer should therefore determine the regulatory pathway before committing significant resources to testing and submission preparation.

5.19 Practical Decision Tree

A simplified decision process for manufacturers can be expressed as follows:

Is the product a medical device?
↓
Determine FDA Classification and Product Code
↓
Is the device exempt from premarket submission?

YES
→ Follow the applicable exemption and remaining FDA requirements.

NO
↓

Is there an appropriate legally marketed predicate?

YES
→ Consider 510(k).

NO
↓

Is the device eligible for De Novo classification?

YES
→ Consider De Novo.

NO
↓

Does the device require PMA?

YES
→ PMA

If the regulatory situation remains unclear:

→ Consider an FDA Pre-Submission to obtain feedback before the formal submission.

This is a planning framework rather than a substitute for a device-specific FDA regulatory determination.

5.20 Key Takeaway

The correct FDA pathway should be the result of a structured regulatory assessment—not a choice based simply on which procedure appears fastest or least expensive.

The fundamental sequence is:

Medical Device → Classification → Product Code → Intended Use → Predicate / Risk → Regulatory Pathway → Evidence → Submission

The three principal pathways are:

• 510(k) – demonstrating substantial equivalence to an appropriate predicate;
• De Novo – establishing classification for certain novel, low- to moderate-risk devices without a predicate;
• PMA – demonstrating safety and effectiveness for devices requiring the highest level of premarket review.

And importantly:

A manufacturer should determine the regulatory pathway before finalizing its testing and evidence strategy.

Getting this decision right at the beginning can prevent unnecessary testing, reduce project delays and ensure that the evidence generated for the product actually supports the FDA submission.

FDA – Premarket Submissions Overview

6. What Needs to Be Done Before Submitting to the FDA?

A common mistake is to view the FDA submission as the starting point of the regulatory process. In reality, the submission is the result of a substantial amount of work that should already have been completed.

Before a manufacturer submits a 510(k), De Novo request, PMA, or another applicable premarket submission, the product, its intended use, its risks, its performance, and the supporting evidence need to be sufficiently defined.

The exact preparation depends heavily on the device and the chosen regulatory pathway. There is therefore no universal checklist that applies identically to every medical device.

Nevertheless, several areas should normally be addressed before a submission is prepared.

6.1 Define the Product and Its Intended Use

The first step is to establish exactly what is being submitted.

The manufacturer should have clearly defined:

• the device and its configuration;
• its intended use;
• its indications for use;
• the intended patient population;
• the intended users;
• the operating environment;
• relevant accessories and components; and
• any important limitations or contraindications.

These elements form the foundation for almost every subsequent regulatory decision.

A change to the intended use can potentially affect the applicable classification, predicate-device selection, testing strategy, clinical evidence requirements, labeling, and even the appropriate premarket pathway.

The regulatory strategy should therefore be established around the actual product and its intended use, rather than around a generic product description.

6.2 Determine the Applicable Regulatory Requirements

The manufacturer should next identify the regulatory requirements applicable to the specific device.

This includes more than simply identifying whether the product is Class I, II, or III. The manufacturer should determine:

• the applicable classification regulation;
• the Product Code;
• applicable General Controls;
• applicable Special Controls;
• whether the device is exempt from 510(k);
• applicable FDA guidance documents;
• applicable performance standards; and
• relevant recognized consensus standards.

FDA maintains a database of Recognized Consensus Standards. These standards can be used to support premarket submissions, and the FDA may accept a Declaration of Conformity where the conditions for using the recognized standard are met. The database should therefore be checked when developing the testing and evidence strategy.

Importantly, an international standard is not automatically an FDA-recognized standard. The manufacturer should verify the specific standard and version in the FDA’s database before relying on it for an FDA submission.

6.3 Establish the Testing Strategy

Testing should not be treated as something that happens immediately before submission.

The manufacturer should first determine which risks and performance characteristics need to be demonstrated and then establish the appropriate test strategy.

Depending on the device, this can include areas such as:

• electrical safety;
• electromagnetic compatibility;
• wireless or radio performance, where applicable;
• software verification and validation;
• cybersecurity;
• mechanical performance;
• biocompatibility;
• sterilization;
• packaging and shelf life;
• usability and human factors;
• accuracy and analytical performance; and
• clinical or other performance testing.

Not every device requires every type of testing.

The appropriate testing program depends on the device’s technology, intended use, risks, applicable regulation, applicable standards, FDA guidance, and submission pathway.

This is one of the areas where pre-compliance or pre-testing can be particularly valuable. Instead of discovering fundamental problems after the formal test program has started, manufacturers can use preliminary testing to identify potential weaknesses and determine which areas require further investigation.

6.4 Establish Risk Management

The manufacturer should also have a structured process for identifying and controlling risks associated with the device.

Risk management should be connected to the actual product design and its intended use. Identified risks can influence:

• design decisions;
• protective measures;
• verification and validation;
• testing;
• labeling;
• warnings and precautions; and
• the overall evidence required to support the submission.

Risk management is therefore not simply a document prepared for the FDA submission. It should be part of the product-development process.

6.5 Consider the Quality Management System

The manufacturer must also consider its quality management obligations.

This is particularly important under the FDA’s Quality Management System Regulation (QMSR), which became effective on February 2, 2026. The QMSR amended the device quality-system requirements in 21 CFR Part 820 and incorporates ISO 13485:2016 by reference.

The QMSR applies to manufacturers of finished medical devices intended for commercial distribution.

This means that FDA compliance is not simply a matter of producing a technically convincing submission. The manufacturer must also understand and meet the quality-system requirements applicable to its activities.

For a company developing a new medical device, the quality system should therefore be considered well before commercial production, rather than being treated as something to establish after FDA clearance or approval.

6.6 Prepare the Technical Documentation

Only after the regulatory strategy, testing strategy, risk assessment, and product information have been established should the manufacturer assemble the submission documentation.

The exact content depends on the submission type.

For example, a 510(k) generally requires information that allows FDA to determine whether the new device is substantially equivalent to the identified predicate device. A PMA requires a substantially different body of evidence addressing safety and effectiveness.

Documentation can include, depending on the device:

• device description;
• intended use and indications for use;
• comparison with a predicate device;
• performance testing;
• test reports;
• software documentation;
• cybersecurity documentation;
• risk-management information;
• biocompatibility information;
• clinical data;
• labeling;
• manufacturing information; and
• declarations or other supporting documentation.

The important point is that these documents should support a coherent regulatory argument. The submission should not simply be a collection of test reports and technical documents.

6.7 Check the Submission Before Filing

Before submission, the manufacturer should perform a final review against the applicable FDA requirements.

The purpose is to identify issues such as:

• missing information;
• inconsistent product descriptions;
• differences between the intended use and labeling;
• incomplete test reports;
• unsupported claims;
• incorrect or outdated standards;
• gaps in risk documentation;
• missing explanations for deviations; or
• inconsistencies between different sections of the submission.

A technically good product can still experience delays if the submission is incomplete or internally inconsistent.

A practical sequence

The preparation can therefore be summarized as:

Define the product → establish intended use → confirm classification → determine regulatory pathway → identify applicable requirements → establish risk and testing strategy → perform testing → compile evidence → prepare submission → conduct final review → submit

The exact sequence may vary depending on the device and pathway, but the underlying principle remains the same:

The FDA submission should be the documented result of the regulatory and technical work—not the beginning of it.

The next chapter will look specifically at what documentation and evidence are typically required for an FDA medical-device submission and why the FDA needs each type of information.

7. What Documents and Evidence Does the FDA Require?

An FDA medical-device submission is not simply a collection of forms and test reports. Depending on the regulatory pathway and the device, the manufacturer must provide a structured body of information that allows the FDA to understand the device, assess its safety and performance, and determine whether the applicable regulatory requirements have been met.

The exact content depends on the pathway. A 510(k), De Novo Classification Request, and PMA can therefore require substantially different evidence. The FDA provides pathway-specific requirements and guidance, and manufacturers should always verify the current requirements before preparing the final submission.

7.1 Administrative Information

A submission normally begins with information that identifies the applicant, the device, and the regulatory context.

Depending on the pathway, this can include:

• applicant or sponsor information;
• device name and model or configuration information;
• Product Code and classification;
• Intended Use and Indications for Use;
• submission type;
• applicable FDA forms and coversheets; and
• references to previous FDA submissions or decisions, where applicable.

These details may appear administrative, but they must be consistent throughout the submission. A different product description, Intended Use, or device configuration in another section can create questions during FDA review.

7.2 Device Description

The FDA needs to understand exactly which device is being evaluated and how it works.

Depending on the product, the Device Description can cover:

• intended function and operating principle;
• major components and materials;
• technology and relevant technical characteristics;
• device configurations and variants;
• accessories and interfaces;
• dimensions and specifications; and
• drawings, photographs, block diagrams, schematics, or other technical representations.

The level of detail should be appropriate to the device and the submission pathway. The purpose is not simply to introduce the product, but to give the FDA enough information to understand the device to which the subsequent testing, risk analysis, and evidence relate.

7.3 Intended Use and Indications for Use

The Intended Use and Indications for Use are among the most important elements of the submission because they define what the manufacturer is claiming the device is intended to do.

They must be consistent with:

• the actual device design;
• risk analysis;
• performance evidence;
• clinical evidence, where required; and
• labeling and other claims.

A broader intended use can have significant regulatory consequences because it may affect the applicable classification, predicate strategy, testing requirements, clinical evidence needs, or regulatory pathway.

The Intended Use should therefore be established before the evidence strategy is finalized rather than being written as an administrative description at the end of the project.

7.4 Predicate Device Comparison for a 510(k)

A 510(k) requires a specific regulatory argument that the new device is substantially equivalent to a legally marketed predicate device.

The comparison can address, depending on the device:

• Intended Use;
• Indications for Use;
• design;
• technological characteristics;
• materials;
• operating principles;
• performance characteristics; and
• differences between the devices.

If differences exist, the manufacturer must explain why they do not raise different questions of safety and effectiveness or provide appropriate evidence addressing those differences.

The predicate comparison is therefore not simply an administrative comparison table. It is a central part of the regulatory reasoning supporting the 510(k).

7.5 Performance and Non-Clinical Testing

The FDA needs objective evidence appropriate to the device and its intended use.

Depending on the product, this may include:

• electrical safety;
• electromagnetic compatibility (EMC);
• wireless or radio performance, where applicable;
• mechanical performance;
• software verification and validation;
• cybersecurity;
• accuracy or analytical performance;
• biocompatibility;
• sterilization;
• packaging and shelf life;
• usability and human factors; and
• other device-specific performance testing.

Not every device requires every type of test. The testing strategy should be derived from the device characteristics, risks, applicable regulation, FDA guidance, recognized standards, and the chosen regulatory pathway.

For 510(k) submissions, FDA may consider bench, animal, and clinical performance data, as applicable. For PMA submissions, the evidence framework is substantially broader and is focused on demonstrating reasonable assurance of safety and effectiveness.

This is also where pre-compliance testing can be useful. Preliminary testing can identify potential weaknesses before the formal evidence-generation program is completed, but it does not replace the evidence required by the applicable FDA pathway.

7.6 Test Reports, Standards and Declarations of Conformity

Performing a test is not sufficient by itself. The evidence must be documented so that the FDA can understand what was tested, under which conditions, and what conclusions can be drawn.

Depending on the test, documentation can include:

• test plan and method;
• applicable standard;
• test conditions and device configuration;
• identification of test samples;
• results;
• deviations;
• evaluation of results; and
• justification for requirements considered not applicable.

When a consensus standard is used, the manufacturer should verify whether the FDA recognizes the specific standard and version. Recognition of a standard is not automatic simply because the standard is internationally or nationally published.

Where the applicable FDA requirements permit it, a manufacturer may use a recognized consensus standard and submit a Declaration of Conformity as part of the supporting evidence.

The FDA’s Recognized Consensus Standards database should therefore be checked when developing the testing strategy.

7.7 Biocompatibility, Sterilization and Device-Specific Evidence

Additional evidence may be required because of how the device interacts with patients, users, or the environment.

For devices that contact the human body, this can include biocompatibility information.

For sterile devices, evidence can include, as applicable:

• sterilization method and validation;
• sterility assurance;
• packaging validation;
• shelf-life information; and
• other device-specific information.

The exact evidence depends on the device, materials, contact characteristics, Intended Use, and applicable FDA requirements.

Manufacturers should therefore avoid treating a generic list of tests as a universal FDA checklist.

7.8 Software and Cybersecurity Documentation

Medical devices containing software may require additional documentation. The scope depends on the role and complexity of the software and the risks associated with the device.

Depending on the product and pathway, documentation can include:

• software description and architecture;
• software requirements and specifications;
• verification and validation;
• software-related risk management;
• identified anomalies and limitations;
• interfaces and dependencies;
• cybersecurity risk controls;
• secure operation; and
• information concerning updates and maintenance.

A simple device with limited software functionality will not necessarily require the same depth of documentation as a complex, network-connected medical device.

The documentation should therefore be proportionate to the device and the applicable FDA requirements.

7.9 Clinical Evidence and Clinical Investigations

Not every medical device requires a clinical study.

For some devices, non-clinical evidence can provide sufficient support. For others, clinical data are necessary to demonstrate safety and effectiveness or to address specific regulatory questions.

Clinical evidence is particularly important for many PMA applications, but it can also be relevant to HDEs, De Novo requests, and some 510(k)s.

The FDA notes that some clinical studies may require an Investigational Device Exemption (IDE) before they are initiated, and the appropriate Institutional Review Board (IRB) requirements must also be considered. Clinical investigations are subject to applicable FDA requirements and Good Clinical Practice requirements.

Where clinical evidence is required, the submission may need information concerning:

• study design and objectives;
• patient population and selection;
• study sites and investigators;
• endpoints and outcome measures;
• safety and effectiveness results;
• adverse events;
• statistical analysis; and
• other information necessary to evaluate the clinical evidence.

The key planning question is therefore not simply:

“Do we have a clinical report?”

but:

“Does this device and regulatory pathway require clinical evidence, and if so, what evidence is sufficient?”

This should be determined early because a clinical investigation can have a major impact on project timing and cost.

7.10 Labeling and Claims

Labeling is an important part of the FDA evidence package and is broader than the physical label attached to the device.

Depending on the product, relevant labeling can include:

• device name;
• Intended Use and Indications for Use;
• Instructions for Use;
• warnings and precautions;
• contraindications;
• limitations;
• safety information; and
• installation or operating instructions.

The claims made in labeling must be consistent with the rest of the submission.

Marketing claims can therefore have regulatory consequences. A claim about what a device can diagnose, monitor, treat, prevent, or otherwise accomplish may affect the regulatory assessment and the evidence required to support the claim.

The FDA identifies labeling as part of the premarket submission requirements, including for PMA applications.

7.11 Manufacturing and Quality-System Information

Depending on the submission type and device, the FDA may require information concerning:

• manufacturing processes;
• materials;
• critical components;
• manufacturing facilities;
• process controls;
• quality controls;
• sterilization processes; and
• process validation.

Manufacturers must also consider their broader quality-system obligations.

This is particularly important because the Quality Management System Regulation (QMSR) became effective on February 2, 2026. The QMSR amended 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. It applies to manufacturers of finished medical devices intended for commercial distribution.

The QMS is not simply a document created for an FDA submission. It is the system through which the manufacturer controls relevant design, production, quality, complaint, and record-related activities.

The amount of manufacturing information included in a particular premarket submission depends on the pathway and device. The existence of a QMSR obligation should therefore not be confused with a requirement to submit the entire quality system as part of every premarket application.

7.12 Risk Management as the Link Between the Evidence

Risk management connects many of the individual evidence elements.

Risks identified for the device can determine:

• design controls;
• protective measures;
• verification and validation;
• performance testing;
• software and cybersecurity controls;
• biocompatibility or other device-specific evidence;
• labeling, warnings, and precautions; and
• whether additional clinical or other evidence is needed.

Risk management should therefore not be treated as a document prepared only because the FDA asks for it.

It should be connected to the actual product development and evidence-generation process.

7.13 UDI and Device Identification

The FDA’s Unique Device Identification (UDI) system is another important regulatory requirement for devices distributed in the United States.

The UDI framework generally requires device labelers to place a UDI on device labels and packages, subject to applicable exceptions and alternatives, and to submit specified device information to the Global Unique Device Identification Database (GUDID).

UDI is not simply another test report or premarket document. It connects the device’s identification information with labeling, distribution, and post-market systems.

The detailed registration, listing, UDI, and GUDID process is addressed later in this guide. At the submission stage, however, manufacturers should ensure that the device identification and labeling strategy are consistent.

7.14 Why Does FDA Need All This Information?

The different documents serve different purposes.

At a high level, the FDA needs to be able to answer three questions:

What is the device?

→ Device Description, Intended Use, Indications for Use, technical information

Does the evidence support the required safety and performance determination?

→ Risk analysis, performance testing, non-clinical evidence, and clinical evidence where necessary

Does the device meet the applicable regulatory requirements?

→ Classification, predicate comparison where applicable, standards, labeling, manufacturing information, and other required evidence

A strong submission connects these elements into one coherent regulatory argument.

The device described in the administrative information should be the same device described in the technical documentation, tested in the reports, evaluated in the risk analysis, and described in the labeling.

7.15 The Key Point for Manufacturers

The documentation should not be treated as an administrative task performed at the end of the project.

A more appropriate sequence is:

Product definition → Intended Use → Classification and regulatory pathway → Risk assessment → Evidence and test strategy → Testing / clinical investigation where required → Technical documentation → Labeling → Submission

The earlier these elements are connected, the lower the risk of discovering immediately before submission that an important piece of evidence is missing or that the evidence does not actually support the Intended Use.

The next chapter explains how the actual FDA submission works, including where it is submitted, the electronic systems used, the role of eSTAR, and what happens after submission.

Official FDA sources

• FDA – How to Study and Market Your Device
• FDA – Quality Management System Regulation (QMSR)
• FDA – UDI Basics
• FDA – Global Unique Device Identification Database (GUDID)

8. How to Submit a Medical Device to the FDA

Once the regulatory pathway has been determined and the required documentation and evidence have been prepared, the manufacturer can move to the actual submission.

The process is largely electronic, but the submission itself is only one step in the FDA review process. The manufacturer must first ensure that the submission is complete, submitted through the correct channel, and accompanied by any applicable user fee.

8.1 FDA Electronic Submissions

FDA’s Center for Devices and Radiological Health (CDRH) uses electronic submission systems for medical-device premarket submissions.

For many submission types, the manufacturer prepares the submission using eSTAR and submits it electronically through FDA’s designated electronic submission process.

eSTAR is not simply a document-upload system. It is an interactive submission template that structures the information required by FDA and can perform certain checks before the submission is finalized.

For 510(k) submissions, FDA generally requires the use of eSTAR unless an applicable exemption applies. The same requirement applies to De Novo requests submitted on or after October 1, 2025, subject to FDA’s stated exceptions.

The manufacturer should therefore verify the current FDA submission requirements before preparing the final package, since electronic submission requirements can change.

8.2 Who Actually Submits the Application?

The manufacturer or applicant is responsible for the submission.

A manufacturer can prepare and submit the application itself or use an external regulatory consultant or other representative to assist with the process.

Using a consultant does not transfer the manufacturer’s regulatory responsibility to that consultant. The manufacturer remains responsible for ensuring that the information submitted to FDA is accurate, complete, and appropriate.

This distinction is important when working with external laboratories or consultants:

A testing laboratory generates test evidence. A regulatory consultant may help prepare the submission. The manufacturer remains responsible for the product and the regulatory submission.

8.3 User Fees

Some FDA premarket submissions are subject to user fees.

The applicable fee depends on the type of submission and, in some cases, on whether the applicant qualifies as a small business under FDA’s criteria.

FDA publishes the current user-fee amounts and eligibility requirements. Because these fees can change between fiscal years, manufacturers should always check the current FDA fee schedule rather than relying on an older fee quotation.

Not every FDA interaction or regulatory activity has the same fee structure. In particular, a device being subject to FDA regulation does not automatically mean that every FDA-related activity requires a user fee.

For planning purposes, the manufacturer should therefore identify the applicable fee before submission and confirm the current amount with FDA.

8.4 What Happens After Submission?

Submitting the dossier does not mean that FDA immediately begins a full technical review.

The submission first goes through FDA’s applicable administrative and acceptance/review process.

FDA checks whether the submission contains the information necessary for the submission to proceed through the relevant review process.

If important information is missing, the submission may not proceed to substantive review as expected.

Once the submission is accepted for review, FDA evaluates the information against the requirements applicable to that particular pathway.

The exact review process depends on whether the submission is, for example, a 510(k), De Novo request, or PMA.

8.5 FDA May Ask Questions

A manufacturer should not assume that submitting the dossier means that no further interaction with FDA will occur.

During review, FDA may identify questions, deficiencies, or areas requiring clarification.

The manufacturer may then need to provide additional information or respond to FDA’s requests.

This is an important reason why the submission should be based on a well-structured technical and regulatory strategy.

If the underlying evidence is incomplete, answering FDA questions can become significantly more difficult than if the relevant information had been generated and documented before submission.

8.6 Additional Testing May Become Necessary

In some cases, FDA’s review may identify a need for additional testing or information.

For example, FDA may determine that:

• an important performance characteristic has not been adequately demonstrated;
• a particular test method is insufficient;
• additional information is required to understand a technological difference;
• the submitted evidence does not adequately address a risk; or
• additional clarification is necessary.

The exact response depends on the submission type and the issue identified by FDA.

This is another reason why manufacturers should avoid designing their testing program solely around the minimum documents they initially expect to submit.

A more robust approach is to understand the regulatory questions the evidence needs to answer before testing begins.

8.7 FDA Decision

The outcome depends on the regulatory pathway.

For a 510(k), FDA determines whether the device is substantially equivalent to the predicate device. If FDA reaches a favorable determination, the device receives 510(k) clearance.

For a De Novo request, FDA determines whether the device should be classified as Class I or Class II based on the information provided.

For a PMA, FDA evaluates whether the submitted evidence provides reasonable assurance of the device’s safety and effectiveness. A favorable decision results in PMA approval.

These outcomes should not be confused with FDA registration or device listing.

A manufacturer can have an establishment registered and a device listed without that meaning that FDA has cleared or approved the individual device.

8.8 What If FDA Does Not Accept or Clear the Submission?

An unfavorable FDA response does not necessarily mean that the product can never be marketed in the United States.

The appropriate next step depends on the reason for the FDA’s decision.

For example, if FDA identifies missing information or deficiencies, the manufacturer may be able to provide additional information or otherwise address the identified issues.

For a 510(k), if FDA determines that the device is not substantially equivalent (NSE), the manufacturer may need to reconsider the regulatory strategy. Depending on the circumstances, this could involve:

• addressing the issues identified by FDA;
• preparing a new 510(k), where appropriate;
• considering whether a De Novo request is applicable; or
• making changes to the device or its intended use and reassessing the regulatory pathway.

The fact that a 510(k) receives an NSE determination does not automatically mean that the product can never reach the U.S. market.

For PMA submissions, FDA may issue a Not Approvable or Approvable letter depending on the deficiencies identified. The manufacturer may be able to respond to the identified deficiencies rather than starting the entire process from zero.

The precise options depend on the FDA decision and the regulatory pathway.

8.9 Can the Product Be Improved and Submitted Again?

Yes.

A manufacturer can generally address deficiencies, modify the device where appropriate, generate additional evidence, and pursue the applicable regulatory pathway again.

However, the correct approach is not simply to “add more documents.”

The manufacturer should first understand why FDA did not accept, clear, or approve the submission.

The problem might be:

• insufficient test evidence;
• an inappropriate test method;
• inadequate risk mitigation;
• an unsuitable predicate;
• differences in Intended Use;
• inadequate clinical evidence;
• labeling problems;
• software or cybersecurity deficiencies;
• manufacturing or quality-system issues; or
• an inappropriate regulatory pathway.

The corrective action should address the underlying regulatory issue.

This can sometimes mean improving the product itself. In other cases, the product is technically acceptable but the evidence demonstrating its safety and performance is insufficient.

8.10 The Cost of Getting It Wrong

The cost of an FDA submission is therefore not limited to the FDA user fee.

A manufacturer may also incur costs for:

• testing;
• laboratory services;
• regulatory consulting;
• clinical investigations;
• product modifications;
• additional test samples;
• additional documentation;
• FDA responses;
• resubmission work; and
• project delays.

This is why the preparation phase is so important.

A manufacturer that identifies regulatory and technical gaps before formal testing and submission has considerably more flexibility to correct them.

A practical overview

The complete process can therefore be viewed as:

Product definition → Classification → Regulatory pathway → Requirements → Risk assessment → Test strategy → Testing → Documentation → Submission → FDA review → Questions/deficiencies → FDA decision → Market entry

The process does not necessarily end with the first FDA response. Depending on the outcome, additional information, corrective actions, or a new submission may be required.

The next chapter will examine what happens after FDA clearance or approval: registration, device listing, U.S. establishment requirements, post-market obligations, and what manufacturers must continue to do after entering the U.S. market.

9. What Happens After FDA Clearance or Approval?

Receiving FDA clearance or approval is a major milestone, but it is not the end of the regulatory process.

Depending on the regulatory pathway, the FDA decision gives the manufacturer the legal basis to market the device in the United States. However, before and during commercial distribution, the manufacturer may still need to complete several additional regulatory activities.

These can include:

• establishment registration;
• device listing;
• UDI assignment and labeling;
• GUDID submission;
• finalizing compliant labeling;
• maintaining the Quality Management System;
• complaint handling;
• Medical Device Reporting (MDR);
• post-market surveillance, where applicable;
• change control;
• annual registration and other ongoing regulatory obligations.

A useful way to look at the process is:

FDA Clearance / Approval
↓
Complete applicable market-entry requirements
↓
Registration & Device Listing
↓
UDI / GUDID
↓
Commercial Distribution
↓
Post-Market Compliance

The exact sequence depends on the device, its regulatory pathway and whether specific requirements apply.

9.1 Clearance and Approval Are Not the Same as Registration

One of the most important distinctions for manufacturers entering the U.S. market is the difference between FDA marketing authorization, establishment registration, and device listing.

These are three different regulatory concepts.

A device can receive a 510(k) clearance, for example, but the manufacturer may still need to complete the applicable establishment registration and device listing before commercial distribution.

Conversely, registration and listing do not mean that FDA has approved or cleared the device.

The FDA explicitly states that establishment registration and device listing do not constitute FDA approval, clearance or authorization.

This distinction is particularly important because companies sometimes advertise products as:

“FDA Registered”

or

“FDA Certified”

These terms can be misleading if they are presented as evidence that the FDA has evaluated and authorized the device.

The FDA does not issue a general “FDA certification” for medical devices simply because an establishment has registered or a device has been listed.

9.2 Establishment Registration

Manufacturers and other establishments that fall within the applicable requirements generally need to register their establishments with the FDA.

This process is called Establishment Registration and is governed by 21 CFR Part 807.

The FDA requires registration from establishments involved in the production and distribution of medical devices intended for commercial distribution in the United States, subject to the applicable regulatory requirements and exemptions.

Foreign manufacturers are included in this system.

A foreign manufacturer also generally needs to designate a U.S. Agent.

9.3 When Does Registration Take Place?

For devices that require premarket authorization, the manufacturer generally must wait until the applicable premarket submission has been cleared or approved before completing the device listing for that device.

The FDA specifically states that a device requiring premarket notification or approval can only be listed after the relevant submission has been cleared or approved.

This means that registration and listing should not be treated as a substitute for the actual premarket authorization.

A simplified sequence is:

Premarket Submission
↓
FDA Clearance / Approval
↓
Establishment Registration
↓
Device Listing
↓
Commercial Distribution

The exact obligations depend on the type of establishment and device.

9.4 Device Listing

Registration and listing are related, but they are not the same activity.

Establishment Registration identifies the facility.

Device Listing identifies the medical devices associated with the establishment and the activities performed on those devices.

For a device requiring premarket authorization, the listing information includes the applicable premarket submission number, such as:

• 510(k);
• De Novo;
• PMA;
• other applicable authorization types.

The listing also includes information such as the proprietary name and the activities performed by the establishment.

9.5 Annual Registration

FDA establishment registration is not a one-time procedure.

Establishments that are required to register generally have to renew their registration annually.

The FDA states that annual registration is completed during the fiscal-year registration period, currently October 1 through December 31.

This is an important distinction from the initial market authorization.

A 510(k) clearance, for example, is not something that the manufacturer simply renews every year in the same way as establishment registration.

The manufacturer must instead maintain the applicable ongoing regulatory obligations.

9.6 Registration Fees

Many establishments that are required to register must also pay an annual establishment registration fee.

The fee is separate from the fees associated with a premarket submission.

For example, the cost structure can potentially include:

Premarket submission fee
+
Annual establishment registration fee
+
Testing / clinical / regulatory costs

The applicable FDA fees can change from year to year.

Manufacturers should therefore always check the FDA’s current fee schedule for the applicable fiscal year rather than relying on historical figures.

9.7 UDI – Unique Device Identification

One of the most important activities after obtaining FDA market authorization is understanding the Unique Device Identification (UDI) requirements.

The FDA established the UDI system to provide a standardized way of identifying medical devices distributed in the United States.

The purpose is to improve the identification of devices throughout their lifecycle, from manufacturing and distribution through use by patients and healthcare providers.

Under the UDI framework, device labelers are generally required to:

1. assign a UDI to the device;
2. place the UDI on the device label and packaging, subject to applicable exceptions and alternatives;
3. submit required device information to the FDA’s Global Unique Device Identification Database (GUDID).

9.8 What Is a UDI?

A UDI – Unique Device Identifier is a unique numeric or alphanumeric identifier used to identify a specific medical device.

The UDI generally consists of two components:

Device Identifier (DI)

The Device Identifier identifies the specific device or device model.

It is the portion of the UDI that identifies, among other things, the labeler and the specific version or model of the device.

Production Identifier (PI)

The Production Identifier provides production-related information where applicable.

Depending on the device, this can include information such as:

• lot or batch number;
• serial number;
• expiration date;
• manufacturing date.

The DI and PI therefore serve different purposes.

A simplified example would be:

UDI = DI + PI

The exact format depends on the issuing agency and the information applicable to the device.

9.9 Who Assigns the UDI?

The FDA does not simply issue a unique number to every manufacturer.

The UDI is developed using a system operated by an FDA-accredited issuing agency.

The FDA currently recognizes accredited issuing agencies for the UDI system.

These organizations provide standards and systems that manufacturers and other labelers use to create UDIs.

The manufacturer therefore needs to establish an appropriate UDI strategy and select an applicable issuing agency before finalizing the device identification and labeling.

9.10 Who Is the “Labeler”?

The UDI requirements use the term labeler.

The labeler is generally the entity that causes a label to be applied to a device, or causes the device label to be modified, with the intention that the device will be commercially distributed without subsequent replacement or modification of the label.

In many cases, this is the manufacturer.

However, the labeler can also be another entity, depending on the business model and activities involved.

The FDA specifically notes that labelers can include, in certain circumstances:

• manufacturers;
• specification developers;
• single-use device reprocessors;
• convenience kit assemblers;
• repackagers;
• relabelers.

This distinction matters because the party responsible for UDI obligations is not necessarily determined solely by who physically manufactures the product.

9.11 What Is GUDID?

GUDID stands for:

Global Unique Device Identification Database

GUDID is an FDA-administered database containing standardized identifying information about medical devices with UDIs.

The database is not simply a copy of the product label.

The information submitted to GUDID is structured around the Device Identifier (DI).

The FDA describes the DI as the key used to obtain the corresponding device information in GUDID.

Importantly:

GUDID contains the Device Identifier. It does not contain the Production Identifier.

Production information such as an individual serial number or lot number is therefore not stored in GUDID in the same way as the device’s basic identifying information.

9.12 Why Does GUDID Exist?

The purpose of GUDID is to create a standardized source of device-identification information.

This can help different participants identify the same medical device consistently, including:

• manufacturers;
• distributors;
• hospitals;
• healthcare professionals;
• patients;
• regulators.

This becomes particularly important when a device is involved in:

• a complaint;
• an adverse event;
• a recall;
• a safety investigation;
• inventory management;
• product tracking.

The UDI system is therefore not simply a labeling exercise.

It is part of the FDA’s broader system for improving the identification and traceability of medical devices.

9.13 What Information Goes Into GUDID?

The FDA requires labelers to submit a defined set of identifying information for applicable devices.

Depending on the device, GUDID information can include elements such as:

• Device Identifier;
• device description;
• proprietary/trade name;
• model or catalog information;
• labeler information;
• device status;
• packaging information;
• relevant product characteristics;
• applicable regulatory information.

The exact data requirements depend on the device and the applicable GUDID data elements.

The FDA’s GUDID Guidance provides detailed recommendations regarding the information that labelers should submit.

9.14 GUDID Is Not FDA Approval

This is another important distinction.

A device appearing in GUDID does not mean that the FDA has approved that device.

GUDID is primarily a device-identification database.

The regulatory authorization, where required, comes from the applicable premarket pathway, such as:

• 510(k) clearance;
• De Novo classification;
• PMA approval.

GUDID serves a different purpose.

Therefore:

FDA Clearance / Approval ≠ Registration ≠ Device Listing ≠ GUDID

These are separate regulatory activities.

9.15 AccessGUDID

The FDA also provides a publicly searchable interface called AccessGUDID.

AccessGUDID allows users to search device identification information.

For example, users can search by:

• device name;
• company;
• Device Identifier.

This can be useful for:

• hospitals;
• healthcare providers;
• distributors;
• manufacturers;
• patients;
• regulatory professionals.

For manufacturers, AccessGUDID can also be useful as a way to verify how device-identification information is publicly represented.

9.16 Preparing for GUDID

UDI and GUDID should not be treated as something that can simply be addressed at the last minute.

Before submitting information to GUDID, the labeler needs to prepare the required information and establish the device’s identification structure.

The FDA’s process includes obtaining a GUDID account and preparing the required device information before submission.

The FDA explicitly requires device labelers to complete the relevant preparation steps before requesting a GUDID account.

A practical preparation process is:

Identify Labeler
↓
Select UDI Issuing Agency
↓
Determine Device Identification Structure
↓
Assign DI / Determine Applicable PI Elements
↓
Update Labeling & Packaging
↓
Prepare GUDID Data
↓
Create GUDID Account
↓
Submit Device Information
↓
Verify Data

9.17 UDI and Labeling

The UDI must generally appear on the device label and packages, subject to the applicable requirements, exceptions and alternatives.

For certain reusable devices that are intended to be reprocessed before each use, the UDI may also need to be directly marked on the device.

The exact marking requirements depend on the device and its characteristics.

The UDI can be represented in both:

• human-readable form, and
• automatic identification and data capture (AIDC) form.

This allows the identifier to be read both by people and by appropriate scanning systems.

9.18 UDI Is More Than a Barcode

A common misunderstanding is:

“UDI means putting a barcode on the package.”

The barcode or other AIDC representation is only one way of encoding the identifier.

UDI is a broader regulatory system consisting of:

Device Identification
+
Production Identification where applicable
+
Labeling / Direct Marking where required
+
GUDID Data Submission

The objective is standardized identification of the device throughout the supply chain and its use.

9.19 What Happens After the Device Enters the Market?

Once the device is commercially distributed, the manufacturer’s regulatory responsibilities continue.

The manufacturer may need to manage:

• complaints;
• adverse events;
• MDR reporting;
• recalls;
• corrections and removals;
• trend analysis;
• changes to the device;
• changes to labeling;
• manufacturing changes;
• supplier changes;
• cybersecurity issues;
• post-market surveillance requirements, where applicable.

The UDI system can support the identification of affected devices when a problem occurs.

For example, if a manufacturing problem affects a particular lot, production information encoded in the UDI can help identify the affected products.

9.20 Changes After Clearance or Approval

FDA clearance or approval does not mean that the manufacturer can make any future modification without regulatory assessment.

Changes can involve:

• hardware;
• components;
• materials;
• software;
• firmware;
• manufacturing processes;
• suppliers;
• production sites;
• labeling;
• intended use;
• indications;
• packaging.

The manufacturer should assess significant changes before implementation.

Depending on the nature of the change and the original regulatory pathway, additional documentation, testing or a new FDA submission may be necessary.

For 510(k) devices in particular, manufacturers must assess whether a modification could significantly affect safety or effectiveness and whether a new 510(k) is required.

The important principle is:

FDA clearance or approval applies to the device as evaluated under the applicable regulatory framework. Significant subsequent changes require their own regulatory assessment.

9.21 Post-Market Obligations

FDA obligations continue throughout the product lifecycle.

Depending on the device and regulatory pathway, these can include:

Complaint Handling

Complaints concerning the device need to be evaluated and handled according to the applicable requirements.

Medical Device Reporting

Certain deaths, serious injuries and malfunctions may trigger MDR reporting obligations.

Corrective Actions

Manufacturers may need to investigate and correct problems identified after market introduction.

Recalls

If a distributed device presents a problem requiring corrective action, a recall may become necessary.

Post-Market Surveillance

Certain devices may be subject to specific post-market surveillance requirements.

PMA Post-Approval Requirements

PMA devices can have additional requirements imposed as conditions of approval, including periodic reporting, post-approval studies or other measures.

9.22 A Complete Post-Authorization View

For a manufacturer, the complete process should therefore be viewed as:

1. FDA Regulatory Pathway

510(k), De Novo, PMA or applicable exemption

↓

2. FDA Decision

Clearance / Classification / Approval

↓

3. Establishment Registration

Register applicable facilities

↓

4. Device Listing

List the applicable device

↓

5. UDI

Establish the device identification

↓

6. GUDID

Submit the required device information

↓

7. Labeling

Ensure compliant UDI and other required labeling

↓

8. Commercial Distribution

Place the device on the U.S. market

↓

9. Post-Market Compliance

Complaints, MDR, corrective actions, recalls and other applicable requirements

↓

10. Lifecycle Management

Assess changes and maintain compliance throughout the product lifecycle.

9.23 A Critical Distinction for Manufacturers

There are several different FDA concepts that are frequently confused:

Concept	What it means
510(k) Clearance	FDA determines that the device is substantially equivalent to an appropriate predicate
De Novo Classification	FDA establishes a classification for a novel device
PMA Approval	FDA determines that the device meets the applicable safety and effectiveness standard for PMA
Establishment Registration	Identifies a facility involved in applicable device activities
Device Listing	Identifies devices associated with a registered establishment
UDI	Unique identification system for the device
GUDID	FDA database containing standardized device-identification information

None of these terms should be used interchangeably.

In particular:

“FDA registered” should never be presented as equivalent to “FDA cleared” or “FDA approved.”

The FDA itself explicitly warns against this misunderstanding.

9.24 Key Takeaway

Obtaining FDA clearance or approval is a major milestone, but it is the beginning of the commercial compliance phase, not the end of FDA regulation.

For many medical devices, the manufacturer still needs to complete applicable:

• establishment registration;
• device listing;
• UDI implementation;
• GUDID submission;
• labeling requirements;
• Quality Management System activities;
• post-market compliance.

The UDI/GUDID system is particularly important because it creates a standardized method for identifying medical devices in the U.S. market.

The practical lifecycle can therefore be summarized as:

Classify → Select Pathway → Submit → Obtain FDA Clearance/Approval → Register → List → Assign UDI → Submit GUDID Data → Market → Monitor → Maintain Compliance

For manufacturers planning U.S. market access, these post-authorization activities should be incorporated into the regulatory project before the FDA submission is completed, rather than treated as administrative tasks after the fact.

10. What Are the Costs of FDA Compliance?

The cost of entering the U.S. market with a medical device cannot be reduced to a single “FDA approval fee.”

The total cost depends on the regulatory pathway, device classification, technical complexity, testing requirements, clinical evidence, the manufacturer’s existing quality system, and the amount of regulatory support required.

For some devices, the FDA-related costs may be relatively manageable. For others, particularly products requiring extensive clinical evidence or a PMA, the overall regulatory investment can be substantial.

It is therefore important to distinguish between FDA fees and the total cost of achieving and maintaining compliance.

10.1 FDA User Fees

Certain FDA premarket submissions are subject to user fees.

The applicable fee depends on the type of submission. FDA publishes the fees for each fiscal year, including reduced fees that may be available to qualifying small businesses.

Examples of submission types that can involve user fees include:

• 510(k);
• De Novo request;
• PMA;
• certain PMA supplements; and
• other specified FDA submissions.

The amount should always be checked against the current FDA fee schedule, because fees can change from one fiscal year to another.

A manufacturer should therefore not use an old quotation or a fee found in an older article when preparing its regulatory budget.

10.2 Small Business Fee Reductions

FDA provides reduced user fees for qualifying small businesses.

The relevant criteria and fee reductions are determined by FDA and must be confirmed for the applicable fiscal year.

Importantly, being a small company does not automatically mean that the manufacturer receives the reduced fee.

The manufacturer must meet FDA’s eligibility requirements and, where required, obtain the appropriate small-business qualification before relying on the reduced fee.

This can make a significant difference when planning the cost of a premarket submission.

10.3 Testing Costs

For many manufacturers, the FDA user fee is only one part of the total cost.

Testing can represent a much larger expense.

Depending on the product, testing may include:

• electrical safety;
• EMC;
• wireless/radio performance;
• mechanical performance;
• software verification and validation;
• cybersecurity;
• biocompatibility;
• sterilization;
• packaging and shelf life;
• chemical characterization;
• usability and human factors; and
• other device-specific performance testing.

The cost varies enormously between products.

A simple non-invasive device may require a relatively limited test program, while a complex active or implantable device may require extensive testing and clinical evidence.

10.4 Clinical Evidence Can Be a Major Cost Driver

Clinical investigations can significantly increase the total cost of an FDA project.

Not every device requires a clinical study, and the clinical evidence required depends on the regulatory pathway and the specific characteristics of the product.

Where clinical evidence is necessary, costs can include:

• study design;
• regulatory and ethical preparation;
• clinical sites;
• investigators;
• patient recruitment;
• monitoring;
• data management;
• statistical analysis;
• reporting; and
• the additional time required to complete the study.

For this reason, determining early whether clinical evidence is likely to be required can have a major impact on both the project budget and schedule.

10.5 Regulatory Consulting

A manufacturer may also use external regulatory support.

Consultants can assist with areas such as:

• classification;
• regulatory pathway selection;
• Predicate Device analysis;
• FDA strategy;
• test planning;
• submission preparation;
• FDA correspondence;
• deficiency responses; and
• postmarket compliance.

Consulting costs depend on the complexity of the project and the amount of work performed externally.

Using a consultant is not mandatory. However, the cost of expert support should be weighed against the potential cost of an incorrect regulatory strategy, unnecessary testing, or a delayed submission.

10.6 Laboratory Costs

Testing laboratories can represent another significant cost category.

The laboratory itself may charge for:

• test preparation;
• test execution;
• test reports;
• additional configurations;
• failed tests;
• retesting;
• engineering time; and
• additional samples.

This is particularly relevant when the manufacturer discovers problems during testing.

A failed test can therefore have a much greater financial impact than the cost of the original test alone.

The manufacturer may have to modify the product, repeat part of the test program, update documentation, and potentially perform additional tests to demonstrate that the corrective action was effective.

10.7 The Cost of a Poorly Defined Test Strategy

One of the most avoidable cost drivers is an unclear testing strategy.

If a manufacturer does not know what needs to be demonstrated, it may:

• perform unnecessary tests;
• omit important tests;
• select unsuitable test methods;
• test the wrong product configuration;
• discover design problems late; or
• need to repeat testing.

This is particularly relevant for pre-compliance and pre-testing.

The objective of pre-testing is not to replace formal FDA evidence generation. Rather, it can help identify potential weaknesses before the manufacturer commits significant resources to the final test program.

For example, if a device has a potential EMC problem, identifying it during an engineering pre-test can give the manufacturer an opportunity to modify the design before formal testing.

10.8 Documentation and Internal Resources

The manufacturer also needs to consider its own internal costs.

Preparing an FDA submission can require substantial effort from:

• regulatory affairs;
• engineering;
• quality assurance;
• software teams;
• clinical teams;
• manufacturing;
• management; and
• other specialists.

Even when no external consultant is used, employee time represents a real project cost.

For a complex device, maintaining consistency between the technical documentation, risk management, test reports, software documentation, labeling, and submission can require considerable internal effort.

10.9 The Cost of Delays

Regulatory delays can sometimes be more expensive than the FDA fees themselves.

A delayed submission can result in:

• postponed product launch;
• delayed revenue;
• additional engineering work;
• additional testing;
• extended consultant or laboratory costs;
• additional project-management effort; and
• delayed market entry.

For products with significant commercial importance, the cost of time can therefore be a major part of the overall regulatory business case.

10.10 What Should Be Included in an FDA Budget?

A realistic budget should therefore consider at least the following categories:

Cost category	Typical relevance
FDA User Fee	Depends on submission type
Small Business qualification	May reduce applicable FDA fees
Regulatory consulting	Optional but potentially significant
Laboratory testing	Often significant
Pre-compliance / engineering testing	Depends on product complexity
Clinical evidence	Required only for certain products
Biocompatibility	Relevant for applicable patient-contact devices
Software & cybersecurity	Relevant for applicable devices
Documentation	Internal and/or external effort
Product modifications	Depends on test and review results
Retesting	Possible if problems are identified
FDA response work	Possible during review
Postmarket compliance	Ongoing

There is therefore no meaningful universal price for “FDA approval.”

Two products sold by the same company can have completely different regulatory costs.

10.11 Why Early Planning Matters

The most important cost-control measure is often not negotiating a lower laboratory price or consultant rate.

It is making the right regulatory and technical decisions early.

Before significant testing begins, the manufacturer should have a clear understanding of:

• the regulatory pathway;
• the applicable requirements;
• the evidence that must be generated;
• the tests that are actually relevant;
• the product configuration that will be tested;
• potential technical risks; and
• the documentation required for the submission.

This allows the manufacturer to identify expensive problems while there is still time to correct them.

The practical takeaway

The cost of FDA compliance is best viewed as a combination of:

FDA fees + testing + clinical evidence where required + regulatory work + internal resources + potential corrective work + ongoing postmarket compliance.

The FDA fee is therefore only one component of the total investment.

For manufacturers, the most effective way to control this investment is to establish the correct regulatory and testing strategy before committing to the full formal test program.

11. Common Mistakes Manufacturers Make When Entering the U.S. Market

FDA compliance projects often do not fail because a manufacturer is technically incapable of meeting the requirements. Problems frequently arise much earlier, when the regulatory strategy, product definition, testing program, or documentation is not aligned with the actual FDA requirements.

Avoiding these mistakes can save substantial time and cost.

11.1 Starting With Testing Instead of the Regulatory Strategy

One of the most common mistakes is to approach a laboratory before determining exactly what the FDA expects to be demonstrated.

A manufacturer may simply ask:

“What tests do we need for this product?”

The answer cannot always be determined from the product category alone.

Before testing begins, the manufacturer should understand:

• the device classification;
• the applicable regulatory pathway;
• the Intended Use;
• relevant FDA guidance;
• applicable recognized consensus standards;
• the safety and performance characteristics that need to be demonstrated; and
• the evidence required for the particular submission.

Otherwise, the manufacturer risks testing the wrong characteristics, using an unsuitable method, or generating evidence that does not adequately support the submission.

11.2 Choosing the Regulatory Pathway Too Late

The regulatory pathway has a major influence on the entire project.

A 510(k), De Novo request, and PMA are not simply different versions of the same application.

They involve different regulatory concepts and different levels of evidence.

For example, a 510(k) generally relies on demonstrating substantial equivalence to a legally marketed predicate device, whereas a De Novo request is intended for certain novel devices for which there is no suitable predicate and which can potentially be classified into Class I or II. PMA follows a substantially different evidence framework for Class III devices.

The regulatory pathway should therefore be established before the testing program is finalized.

11.3 Selecting a Predicate Device Without Sufficient Analysis

For a 510(k), the selection of the predicate device is particularly important.

A manufacturer should not simply select a device because it appears similar or has a similar product name.

The manufacturer needs to consider factors such as:

• Intended Use;
• Indications for Use;
• technological characteristics;
• design;
• performance;
• materials; and
• other relevant characteristics.

The predicate needs to provide a credible basis for the substantial-equivalence argument.

A weak predicate strategy can create significant problems later in the submission.

11.4 Assuming That an International Standard Is Automatically Accepted

Manufacturers often work with standards used in Europe or other markets and assume that the same standards can automatically be used to support an FDA submission.

That assumption is unsafe.

FDA maintains its own list of Recognized Consensus Standards. A standard should therefore be checked against the FDA’s current recognition information before it is relied upon for a submission.

Even where FDA recognizes a standard, the manufacturer still needs to consider whether the standard is applicable to the specific device and whether the testing performed adequately addresses the regulatory question.

The existence of a standard does not automatically mean that performing the standard’s tests is sufficient.

11.5 Treating the European Documentation as the FDA Submission

A manufacturer that already has CE-marking documentation may assume that the existing technical documentation can simply be submitted to FDA.

This is generally not a safe approach.

European and U.S. regulatory systems have different structures and terminology.

For example:

• CE marking is based on the applicable European regulatory framework;
• FDA uses its own classification and submission pathways;
• a European technical file is not automatically an FDA submission;
• the role of standards can differ; and
• the required evidence depends on the FDA pathway.

Existing European documentation can nevertheless be extremely useful.

Test reports, risk-management documentation, clinical information, software documentation, and other technical evidence may be reusable where appropriate.

The key is to determine what can be reused and what needs to be supplemented or reformatted for FDA.

11.6 Defining the Intended Use Too Broadly

The Intended Use and Indications for Use are fundamental elements of the regulatory strategy.

A manufacturer may be tempted to describe the product as broadly as possible to maximize its commercial potential.

However, broader claims can also increase the regulatory evidence required to support those claims.

The manufacturer should therefore define the Intended Use carefully and ensure that:

product design + risk analysis + testing + clinical evidence, where required + labeling

all support the same intended use.

Changing the intended use later can also have significant regulatory consequences.

11.7 Leaving Labeling Until the End

Labeling is sometimes treated as something that can be finalized after the technical work has been completed.

This can create problems.

The claims made in the labeling influence how FDA understands the device and what the manufacturer is claiming about its safety and performance.

A claim that appears commercially attractive may require additional evidence.

Labeling should therefore be developed in parallel with the regulatory and technical strategy rather than being written only immediately before submission.

11.8 Assuming That a Successful Test Automatically Means FDA Compliance

Passing a test does not automatically mean that the device satisfies all FDA requirements.

A test result answers a particular technical question.

FDA evaluates the overall evidence in the context of the applicable regulatory pathway.

A device can therefore pass individual tests and still have a regulatory problem because, for example:

• the wrong regulatory pathway was selected;
• the Intended Use is not adequately supported;
• another relevant risk has not been addressed;
• the predicate strategy is inadequate;
• labeling is inconsistent with the evidence; or
• required documentation is missing.

Testing is therefore one component of the regulatory argument, not the entire regulatory argument.

11.9 Discovering Problems for the First Time During Formal Testing

Formal testing is an expensive point at which to discover fundamental design problems.

If the product fails during a formal laboratory program, the manufacturer may have to:

1. identify the root cause;
2. modify the design;
3. evaluate the modification;
4. determine whether additional risks have been introduced;
5. repeat testing; and
6. update the technical documentation.

Depending on the problem, this can have a substantial effect on both cost and schedule.

This is where appropriately designed pre-compliance testing can provide value.

The purpose is to identify potential weaknesses early, when design changes are still relatively manageable.

11.10 Treating FDA Submission as a Purely Administrative Exercise

An FDA submission is not simply a collection of documents.

The submission needs to present a coherent regulatory argument:

This is our device → this is its intended use → this is its regulatory pathway → these are the relevant risks → these are the characteristics that need to be demonstrated → this is the evidence → this evidence demonstrates the required safety and performance.

If the individual documents do not support the same story, the submission becomes more difficult to evaluate.

Consistency is therefore critical.

11.11 Ignoring the Postmarket Phase

Another common mistake is to consider FDA compliance finished once clearance or approval has been obtained.

As discussed in the previous chapter, manufacturers may continue to have obligations concerning:

• registration and listing;
• quality management;
• complaint handling;
• MDR;
• recalls and corrective actions;
• product changes; and
• additional postmarket requirements where applicable.

The regulatory strategy should therefore cover the entire product lifecycle, not only the initial market-entry submission.

11.12 Assuming That a Consultant or Laboratory Takes Over Regulatory Responsibility

External specialists can provide valuable support, but the manufacturer remains responsible for its product and regulatory compliance.

A laboratory can perform testing.

A consultant can provide regulatory advice.

Neither automatically becomes responsible for the manufacturer’s overall compliance.

The manufacturer should therefore maintain internal ownership of:

• the product definition;
• Intended Use;
• regulatory strategy;
• risk decisions;
• evidence;
• final documentation; and
• regulatory decisions.

11.13 The Better Approach

Most of these mistakes have the same underlying cause:

The regulatory strategy is developed too late.

A more effective approach is to work backwards from the regulatory objective:

What do we want to market?
→ What is the Intended Use?
→ How is the device classified?
→ Which FDA pathway applies?
→ What does FDA need to see?
→ Which risks and performance characteristics must be demonstrated?
→ Which tests and other evidence provide that demonstration?
→ What documentation is required?
→ Is the complete package internally consistent?

This approach allows testing, engineering, quality, regulatory affairs, and documentation to work toward the same objective rather than being handled as separate activities.

The practical takeaway

The most expensive FDA mistakes are often made before the first formal submission is ever filed.

A well-defined regulatory strategy and evidence plan can reduce unnecessary testing, avoid late design changes, and make the eventual submission substantially more predictable.

12. FDA Compliance Throughout the Product Lifecycle

FDA compliance should not be treated as a single project that ends when a medical device receives clearance or approval. For manufacturers, compliance is an ongoing process that begins during product development and continues throughout the commercial life of the device.

The regulatory decisions made early in development can influence testing, documentation, manufacturing, labeling, postmarket obligations, and future product changes.

A structured lifecycle approach therefore helps manufacturers avoid treating each regulatory activity as an isolated task.

12.1 From Product Idea to Market Entry

The FDA lifecycle begins before a formal submission is prepared.

A typical process can be represented as:

Product concept → Intended Use → Classification → Regulatory pathway → Requirements → Risk management → Design → Testing → Documentation → FDA Submission → Clearance/Approval → Registration & Listing → Manufacturing → Postmarket monitoring → Changes and corrective actions

The individual stages are connected.

For example, the Intended Use can influence classification. Classification influences the available regulatory pathways. The chosen pathway determines what evidence is needed. That evidence influences the testing and documentation strategy.

A decision made at the beginning can therefore affect the entire project.

12.2 Product Development and Regulatory Strategy

Regulatory considerations should be incorporated into product development rather than added immediately before market launch.

During development, the manufacturer should establish:

• the intended purpose of the device;
• the target patient population and use environment, where applicable;
• the expected technological characteristics;
• foreseeable risks;
• applicable regulatory requirements; and
• the likely FDA pathway.

This allows engineering decisions to be evaluated against the eventual regulatory requirements.

It also reduces the risk of developing a product first and discovering later that significant design changes are necessary to support the intended market.

12.3 Risk Management Throughout the Lifecycle

Risk management is not limited to the initial design phase.

Risks should be reviewed when relevant new information becomes available, including information generated through:

• testing;
• design changes;
• complaints;
• manufacturing issues;
• adverse events;
• field experience; and
• postmarket surveillance.

A change introduced to solve one problem can also introduce a new risk.

The manufacturer therefore needs a process for evaluating the effect of design and manufacturing changes on the overall risk profile.

12.4 Testing Is Part of the Evidence Strategy

Testing should be linked to the regulatory questions that need to be answered.

The manufacturer should be able to explain:

What characteristic are we evaluating?
Why is it relevant?
What risk or regulatory requirement does it address?
Which test or other evidence demonstrates compliance?

This approach is more effective than simply creating a large list of standards and testing everything that appears potentially relevant.

Testing should also be planned around the final intended product configuration.

If the tested configuration differs significantly from the device that will ultimately be marketed, the manufacturer may need to evaluate whether the existing evidence remains applicable.

12.5 Pre-Compliance Testing Has a Specific Role

Pre-compliance testing can be particularly useful during development.

Its purpose is to identify potential problems before formal compliance testing or submission-related evidence generation.

Examples can include identifying:

• EMC problems;
• excessive emissions;
• susceptibility issues;
• thermal problems;
• electrical safety concerns;
• wireless performance issues; or
• other technical weaknesses.

The manufacturer can then modify the design and repeat the relevant engineering evaluation before committing to the final formal test program.

Pre-compliance testing should therefore be viewed as a risk-reduction tool, not as a replacement for the formal evidence required by the applicable FDA pathway.

12.6 Preparing the FDA Submission

Once the product, regulatory pathway, testing strategy, and evidence package have been sufficiently established, the manufacturer can prepare the FDA submission.

At this stage, the individual elements should form a consistent package.

The manufacturer should be able to connect:

Intended Use → device characteristics → risks → applicable requirements → test methods → results → conclusions → labeling

Any significant inconsistency can create additional questions during FDA review.

This is why submission preparation should not be treated simply as collecting documents from different departments.

The submission should tell a coherent regulatory story.

12.7 FDA Review and Possible Additional Work

FDA review may result in questions or requests for additional information.

The manufacturer may need to provide:

• clarifications;
• additional technical information;
• revised documentation;
• additional test results;
• additional analyses; or
• other evidence relevant to the FDA’s questions.

The amount of additional work depends on the submission and the issues identified during review.

A well-prepared submission can reduce unnecessary clarification, but it cannot guarantee that FDA will not ask questions.

12.8 Manufacturing and Quality After Clearance or Approval

Once the device is commercially manufactured, the manufacturer must continue operating within the applicable quality requirements.

The product should be manufactured consistently with the specifications and processes supporting its regulatory status.

Manufacturing changes, supplier changes, process changes, and other modifications should therefore be evaluated through the manufacturer’s established change-control processes.

This becomes particularly important when a change could affect:

• safety;
• performance;
• materials;
• software;
• manufacturing processes;
• labeling; or
• the regulatory basis for the device.

12.9 Postmarket Information Feeds Back Into the Product

The lifecycle does not move only in one direction.

Information generated after market entry can feed back into the development and risk-management process.

For example:

Complaint → investigation → risk assessment → corrective action → design or process change → verification/validation → regulatory assessment

This feedback loop allows manufacturers to respond to new information and maintain control over the product throughout its commercial life.

12.10 Changes Require Regulatory Assessment

Medical devices rarely remain completely unchanged throughout their commercial life.

Manufacturers may introduce:

• new software versions;
• hardware updates;
• new components;
• alternative suppliers;
• manufacturing-process changes;
• new packaging;
• updated labeling; or
• new indications or claims.

Before implementing a change, the manufacturer should determine whether the change affects the device’s existing FDA regulatory status.

Depending on the nature of the change, this may require only internal documentation and evaluation, or it may trigger additional regulatory activities.

The important principle is:

Do not assume that a change is regulatory-neutral. Assess it before implementation.

12.11 End of Product Life

The lifecycle also includes the eventual discontinuation of the product.

When a manufacturer stops producing or marketing a device, it may need to update relevant FDA registration or listing information and maintain applicable records and postmarket responsibilities.

The exact obligations depend on the manufacturer’s role and the circumstances of the discontinuation.

The regulatory lifecycle therefore does not simply end when the last product leaves the factory.

12.12 A Lifecycle Approach Reduces Regulatory Risk

A lifecycle-based approach allows manufacturers to connect activities that are often managed separately:

Engineering ↔ Regulatory Affairs ↔ Quality ↔ Testing ↔ Manufacturing ↔ Postmarket Surveillance

This is particularly valuable for complex medical devices, where a change in one area can have consequences elsewhere.

For example, an engineering change may affect the risk analysis, which may affect testing, which may affect the regulatory documentation and potentially the need for additional FDA interaction.

Treating these activities as connected processes makes such consequences easier to identify.

The practical takeaway

FDA compliance is not a single approval event.

It is a continuous lifecycle of defining, demonstrating, maintaining, monitoring, and reassessing compliance.

For manufacturers, the most effective strategy is therefore to establish regulatory control early and maintain it throughout the entire life of the device.

13. FDA Requirements for Foreign Manufacturers and Importing into the United States

For a manufacturer located outside the United States, the FDA process does not end with obtaining clearance or approval for a medical device.

A European manufacturer that wants to market a medical device in the United States must also meet the requirements that apply to foreign establishments, establishment registration, device listing, the U.S. Agent, and importation.

This is particularly important for manufacturers in Germany and other European countries because the FDA does not consider an existing CE marking, ISO 13485 certification, or authorization in another country to be a substitute for applicable U.S. requirements.

The FDA makes clear that foreign manufacturers must comply with applicable U.S. requirements before, during, and after importation of their medical devices.

13.1 What Is a Foreign Manufacturer?

A Foreign Manufacturer is generally a manufacturer whose manufacturing establishment is located outside the United States.

Such a manufacturer may be subject to FDA requirements even if the company already has:

• CE marking;
• ISO 13485 certification;
• regulatory approvals in other countries;
• an established quality management system; or
• extensive regulatory experience in other markets.

Approval or authorization in another country does not replace the applicable FDA requirements.

The U.S. regulatory status of a medical device must therefore be assessed independently from its regulatory status in Europe or other markets.

13.2 The U.S. Agent

One of the important additional requirements for foreign manufacturers is the appointment of a U.S. Agent.

A foreign establishment that manufactures, prepares, propagates, compounds, or processes a medical device that is imported into the United States generally must designate a U.S. Agent.

The U.S. Agent must:

• reside in the United States or maintain a place of business in the United States;
• have a physical U.S. address;
• be available to FDA; and
• agree to act as the U.S. Agent.

A post-office box alone is not sufficient. The FDA also specifies that an answering service cannot serve as the U.S. Agent.

13.3 What Does the U.S. Agent Do?

The U.S. Agent is not simply a U.S. distributor or importer.

Its role is primarily to facilitate communication between the FDA and the foreign establishment.

The U.S. Agent may be involved in:

• communication between FDA and the foreign manufacturer;
• responding to FDA questions concerning the imported or offered-for-import device;
• coordinating FDA inspections of the foreign establishment; and
• forwarding information or documents when FDA cannot directly or quickly contact the foreign manufacturer.

The U.S. Agent does not automatically assume the manufacturer’s regulatory responsibilities.

For example, the FDA specifically distinguishes the U.S. Agent from responsibilities such as submitting a 510(k) or fulfilling the manufacturer’s Medical Device Reporting obligations.

The U.S. Agent therefore does not replace the manufacturer’s own Regulatory Affairs function.

13.4 The U.S. Agent and Initial Importer Are Not the Same

These two roles are frequently confused.

The U.S. Agent primarily serves as the communication link between FDA and the foreign establishment.

The Initial Importer, on the other hand, is generally the entity in the United States that imports the device and distributes it further until it reaches the final customer or user, without performing certain activities such as repackaging or changing the labeling.

Depending on the company’s structure, different entities may perform these roles. They should not, however, automatically be treated as the same role.

Before entering the U.S. market, the manufacturer should therefore establish:

Who is the manufacturer?
Who is the U.S. Agent?
Who is the Initial Importer?
Who is responsible for which regulatory activities?

13.5 Registration of the Foreign Manufacturer

A foreign manufacturer whose medical devices are intended for commercial distribution in the United States generally needs to complete the applicable FDA Establishment Registration.

FDA requires applicable establishments to register annually. The exact registration obligations depend on the activities performed by the establishment.

For a foreign manufacturer, the registration process can include information concerning:

• the establishment;
• the activities performed;
• the medical devices manufactured or processed;
• the U.S. Agent; and
• other information required by FDA.

Registration is performed electronically through the FDA’s applicable registration system.

13.6 Device Listing

In addition to establishment registration, the medical device generally also needs to be listed with FDA when listing is required.

Registration and listing are two different processes.

Registration essentially addresses:

Who is the regulated establishment?

Device listing addresses, among other things:

Which medical devices are manufactured or processed by that establishment?

The FDA maintains registration and listing information for medical device establishments and products.

For a device requiring a premarket submission such as a 510(k) or PMA, the device listing generally follows the applicable clearance or approval rather than preceding it.

This distinction is important for project planning.

13.7 Registration Is Not FDA Approval

Another important distinction is that FDA registration does not mean that FDA has approved the company or its product.

A company can be registered with FDA and have a device listed without that meaning the specific device has received FDA clearance or approval.

These concepts should therefore be kept separate:

Establishment Registration → Device Listing → Premarket Clearance/Approval

Each has a different regulatory purpose.

This is also why statements such as:

“FDA Registered”

must not be presented as equivalent to:

“FDA Cleared”

or

“FDA Approved.”

They describe different regulatory statuses.

13.8 What Happens When the Device Is Imported?

When a foreign manufacturer imports a medical device into the United States, FDA can verify whether the relevant information concerning the manufacturer, importer, and device is consistent with the FDA’s records and applicable requirements.

Among other things, the import process can involve verification that the relevant establishment is registered and that the device is properly listed when listing is required.

If required information is missing or inconsistent, FDA may request additional information or take action affecting the admission of the product into the United States.

Importation should therefore not be viewed solely as a logistical process.

The regulatory information associated with the manufacturer, device, U.S. Agent, and importer must be properly established and maintained.

13.9 The Manufacturer Remains Responsible for Its Device

A common misconception is that appointing a U.S. distributor or importer transfers the foreign manufacturer’s FDA responsibilities to that U.S. company.

That is not generally the case.

The foreign manufacturer remains responsible for its own applicable regulatory obligations.

Depending on the product and the manufacturer’s role, these may include:

• compliance with applicable FDA requirements;
• establishment registration;
• device listing;
• quality requirements;
• labeling;
• complaint handling;
• Medical Device Reporting obligations;
• cooperation with FDA inspections; and
• regulatory assessment of product changes.

The responsibilities of the manufacturer, U.S. Agent, and Initial Importer should therefore be clearly defined both organizationally and contractually.

13.10 FDA Inspections of Foreign Manufacturers

Being located outside the United States does not place a manufacturer outside FDA oversight.

FDA can inspect foreign manufacturing establishments.

This means that a German or other European manufacturer should not view FDA compliance as exclusively a documentation exercise for market entry.

The manufacturer’s quality and manufacturing systems should also be capable of demonstrating compliance with the applicable FDA requirements.

A potential FDA inspection should therefore be considered part of the overall U.S. regulatory strategy.

13.11 The Role of the Initial Importer

The Initial Importer can also have its own FDA obligations.

For example, an Initial Importer generally needs to register with FDA and identify the foreign manufacturers whose devices it imports.

This creates a regulatory connection between:

Foreign Manufacturer ↔ U.S. Agent ↔ Initial Importer ↔ FDA

The respective roles should be established before the first commercial shipment.

13.12 What Should a European Manufacturer Clarify Before the First Import?

Before the first shipment to the United States, the manufacturer should have clearly established at least the following:

Question	Why is it relevant?
Which establishment is the manufacturer?	Determines the applicable FDA registration
Who is the U.S. Agent?	Required for applicable foreign establishments
Who is the Initial Importer?	The importer may have its own FDA obligations
Is the device correctly classified?	Determines the regulatory framework
Is a premarket submission required?	Clearance or approval may be required before marketing
Is the device properly listed?	Required where applicable
Is the labeling FDA-compliant?	Part of the overall market-entry and compliance strategy
Are the applicable quality requirements addressed?	Ongoing compliance obligation
Are complaint and MDR processes established?	Important for postmarket compliance
Are manufacturer, U.S. Agent, importer, and device information consistent?	Helps avoid regulatory and import problems

13.13 An Important Difference from Europe

For European manufacturers, it is particularly important not to transfer the European CE-marking model directly to the U.S. system.

A European company may already have:

• CE marking;
• ISO 13485 certification;
• a European Authorized Representative; and
• extensive technical documentation.

None of these automatically establishes compliance with all applicable U.S. FDA requirements.

The entire U.S. market-entry structure must therefore be assessed against the FDA framework.

The practical takeaway

For a foreign manufacturer, entering the U.S. market involves considerably more than obtaining the appropriate premarket clearance or approval.

The overall structure can be summarized as:

Regulatory Pathway → Required Clearance/Approval → Establishment Registration → Device Listing → U.S. Agent → Initial Importer → Importation → Ongoing FDA Compliance

A manufacturer that considers these organizational and import requirements only after completing the technical regulatory process may create unnecessary delays before the product can actually reach the U.S. market.

For European manufacturers, the key question is therefore not only:

“Is our device FDA cleared or approved?”

but also:

“Are we, as a foreign manufacturer, organizationally and regulatorily prepared to actually market and import this device in the United States?”

14. Quality Management, Labeling and Postmarket Obligations

Obtaining FDA clearance or approval is not the end of the regulatory process. Once a medical device is marketed in the United States, the manufacturer must continue to meet applicable requirements relating to quality, manufacturing, labeling, complaint handling, adverse-event reporting, corrections and other postmarket activities.

For manufacturers entering the U.S. market, this is an important distinction:

FDA market access gives the manufacturer the basis to market the device. It does not remove the manufacturer’s ongoing regulatory responsibilities.

14.1 The Quality Management System

Quality management is a fundamental part of FDA medical device regulation.

As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) is effective. The QMSR amended 21 CFR Part 820 and incorporates by reference ISO 13485:2016 for medical device quality management systems. The FDA states that the requirements of ISO 13485, taken as a whole, are substantially similar to the previous FDA Quality System Regulation.

This change is particularly relevant for European manufacturers because ISO 13485 is already widely used internationally.

However, an important distinction remains:

Having an ISO 13485 certificate does not by itself mean that every FDA requirement has been fulfilled.

The QMSR is an FDA regulation. ISO 13485 is incorporated into that regulation, but additional FDA requirements and interpretations continue to apply.

The manufacturer’s quality system therefore needs to be assessed against the actual requirements applicable to its activities.

14.2 What Does the Quality System Need to Control?

A medical device manufacturer’s quality system provides the framework for controlling how the device is designed, manufactured, evaluated, released and maintained.

Depending on the manufacturer and device, relevant processes can include:

• design and development;
• risk management;
• supplier controls;
• purchasing;
• production and process controls;
• verification and validation;
• change control;
• document control;
• complaint handling;
• nonconforming products;
• corrective and preventive actions;
• records; and
• monitoring and measurement.

The purpose is not simply to create documentation.

The quality system should provide evidence that the manufacturer can consistently produce devices that meet their specified requirements and applicable regulatory requirements.

14.3 Design Controls and Product Changes

For applicable devices, design and development controls are an important part of the quality system.

The manufacturer needs to maintain control over the transition from:

Design Input → Design Development → Verification → Validation → Design Transfer → Production

The exact requirements depend on the applicable regulatory framework and the nature of the device.

This becomes particularly important when the product is modified after FDA clearance or approval.

A manufacturer should not assume that a seemingly small engineering change has no regulatory significance.

Examples include:

• changing a component;
• changing a supplier;
• modifying hardware;
• changing software;
• changing materials;
• modifying manufacturing processes;
• changing packaging; or
• changing labeling or product claims.

The manufacturer should evaluate the change through its change-control process and determine whether additional verification, validation, documentation or regulatory action is required.

14.4 Labeling Requirements

Medical device labeling is another important area of ongoing FDA compliance.

The FDA’s general device labeling requirements are contained in 21 CFR Part 801. The requirements establish minimum labeling provisions, with additional requirements applying to certain types of devices.

Labeling is not limited to the information printed directly on the physical device.

Depending on the product, the overall labeling framework can involve information such as:

• device identification;
• manufacturer information;
• intended use;
• directions for use;
• warnings;
• precautions;
• contraindications;
• operating instructions; and
• other information necessary for safe and appropriate use.

The exact requirements depend on the device and its regulatory status.

14.5 Labeling Must Match the Regulatory Evidence

One of the most important principles is consistency between the product claims and the evidence supporting those claims.

For example, a manufacturer should not introduce a new claim simply because the product technically appears capable of performing an additional function.

The manufacturer needs to consider whether the new claim is supported by:

• the intended use;
• risk analysis;
• verification and validation;
• performance testing;
• clinical evidence, where applicable;
• labeling; and
• the existing FDA regulatory basis.

This is particularly important when marketing teams modify product claims after clearance or approval.

A change in wording can sometimes have regulatory consequences.

14.6 Complaint Handling

Once a device is commercially available, the manufacturer needs a system for receiving and evaluating complaints.

A complaint may contain information concerning:

• device malfunction;
• performance problems;
• labeling issues;
• user problems;
• safety concerns;
• adverse events; or
• other product-related issues.

The manufacturer needs to determine whether the information represents a reportable event, requires investigation, indicates a quality problem, or suggests that corrective action may be necessary.

Complaint handling therefore connects several areas of the manufacturer’s quality and regulatory system.

A simplified process can look like:

Complaint → Evaluation → Investigation → Risk Assessment → MDR Assessment → Corrective Action, if required

Not every complaint results in an FDA report or corrective action. Each complaint needs to be evaluated according to the applicable procedures and requirements.

14.7 Medical Device Reporting (MDR)

The FDA’s Medical Device Reporting regulation, 21 CFR Part 803, establishes mandatory reporting requirements for certain device-related adverse events and malfunctions.

For manufacturers and importers, reportable events can include situations in which a device:

• may have caused or contributed to a death or serious injury; or
• malfunctioned in a way that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Manufacturers generally have to submit individual MDR reports within the applicable regulatory timeframe once they become aware of a reportable event.

The FDA identifies 30 days as the general reporting period for individual manufacturer reports under 21 CFR 803.50, with additional requirements applying in certain circumstances.

There are also specific requirements for certain five-day reports and other MDR-related processes.

The manufacturer therefore needs a documented MDR procedure rather than evaluating each potential event informally.

14.8 Electronic MDR Reporting

Manufacturers and importers generally submit MDR reports electronically.

The FDA’s current electronic MDR system uses the Electronic Submissions Gateway (ESG) NextGen Unified Submission Portal.

The FDA states that, since April 14, 2025, the ESG NextGen Unified Submission Portal has replaced the previous WebTrader interface.

This means that manufacturers planning to market a device in the United States should establish the necessary reporting processes before the product is commercially distributed.

Postmarket reporting should not be designed only after the first incident occurs.

14.9 Corrective Actions and Removals

Not every product problem requires a recall.

However, when a manufacturer identifies a safety or compliance problem, it must determine what action is appropriate.

Possible responses can include:

• investigation;
• correction of the product;
• software update;
• customer notification;
• replacement;
• removal of products from the market; or
• recall.

The appropriate regulatory treatment depends on the nature and severity of the problem.

The manufacturer should therefore have procedures that allow it to identify, assess and control potentially defective or nonconforming devices.

14.10 Postmarket Surveillance

Postmarket information provides an important source of information about the real-world performance of a device.

The manufacturer may receive information through:

• complaints;
• distributors;
• healthcare professionals;
• patients;
• service organizations;
• adverse-event reports;
• returns;
• field observations; and
• other sources.

This information can reveal issues that were not apparent during product development or premarket testing.

The manufacturer should therefore use postmarket information as an input to its ongoing risk and quality processes.

14.11 FDA Inspections After Market Entry

FDA oversight does not stop once a device has entered the market.

The FDA can inspect medical device manufacturing establishments to assess compliance with applicable requirements.

Since February 2, 2026, the FDA has used its updated inspection process aligned with the QMSR rather than the previous Quality System Inspection Technique (QSIT).

During an inspection, the FDA may review relevant quality-system records and processes.

The FDA specifically states that records such as management review, quality audits and supplier audit reports can be subject to inspection under the QMSR.

A manufacturer should therefore treat inspection readiness as a permanent state rather than preparing documents only when an inspection is announced.

14.12 What Manufacturers Should Have in Place Before Launch

Before commercial distribution begins, a manufacturer should not only have the market-entry documentation ready.

It should also have the infrastructure necessary to maintain compliance.

Depending on the product and regulatory pathway, this can include:

Area	Purpose
Quality Management System	Control design and manufacturing
Change Control	Evaluate product and process changes
Complaint Handling	Capture and evaluate field problems
MDR Procedure	Identify and report reportable events
CAPA Processes	Address recurring or systemic problems
Labeling Control	Maintain compliant product information
Supplier Controls	Manage critical external suppliers
Postmarket Monitoring	Detect emerging product risks
Recall/Correction Procedure	Respond to significant product problems
Regulatory Assessment	Determine the impact of changes

The exact requirements depend on the manufacturer, device and applicable FDA regulations.

14.13 The Regulatory Lifecycle Continues After Approval

The relationship between the manufacturer and the FDA does not end when a device receives clearance or approval.

The lifecycle can be represented as:

Development → Submission → Clearance/Approval → Manufacturing → Distribution → Complaint Handling → Postmarket Monitoring → Change Control → Corrective Action, where required

Information from one stage can affect another.

For example:

Postmarket complaint → previously unknown risk → risk assessment → design change → verification/validation → regulatory assessment

This is why FDA compliance should be managed as an integrated system rather than as a one-time approval project.

14.14 The Practical Takeaway

The most important point for manufacturers is simple:

FDA compliance does not end when the product reaches the U.S. market.

The manufacturer must continue to control the product, its manufacturing processes, its labeling, its quality system and its postmarket information.

For companies already familiar with ISO 13485, the FDA’s QMSR, effective since February 2, 2026, creates a much closer connection between the U.S. quality-system framework and the internationally recognized ISO 13485 approach. However, manufacturers still need to understand and address the specific FDA requirements applicable to their devices and activities.

The goal is therefore not simply to obtain FDA clearance or approval, but to establish a system that allows the manufacturer to maintain compliance throughout the entire commercial life of the device.

15. FDA Fees and Costs for Medical Devices

FDA compliance involves more than the cost of testing and preparing a regulatory submission. Depending on the device, regulatory pathway, company structure, and activities performed in the United States, manufacturers may face several different types of costs.

Understanding these costs early is important because some FDA fees are mandatory, while others arise from the technical and regulatory work required to prepare a successful submission.

For manufacturers, the relevant question is therefore not simply:

“How much does FDA approval cost?”

The better question is:

“What costs will our specific device, regulatory pathway, and U.S. market-entry structure create?”

15.1 FDA Fees Are Not the Same for Every Device

There is no single fixed FDA fee for medical devices.

The applicable fees depend primarily on the regulatory activity involved.

Examples include:

• establishment registration fees;
• premarket submission fees;
• certain annual fees;
• requests for additional FDA services; and
• other fees applicable to specific regulatory activities.

The FDA publishes the applicable medical device user fees for each fiscal year.

For the FY 2026 fee schedule, for example, the FDA publishes separate fees for different types of submissions and establishments. The amounts can also differ depending on whether a company qualifies as a small business.

Therefore, fee information should always be checked against the current FDA fiscal-year fee schedule rather than relying on an older article or quotation.

15.2 Premarket Submission Fees

One of the most important potential FDA costs is the fee associated with the applicable premarket submission.

Depending on the regulatory pathway, this can include fees for:

• 510(k) submissions;
• De Novo requests;
• PMA submissions;
• PMA supplements; and
• certain other submission types.

The FDA publishes separate fees for these submission categories.

The amount paid to FDA is only one part of the total cost of obtaining market access.

The manufacturer may also need to pay for:

• regulatory consulting;
• testing;
• laboratory services;
• clinical investigations, where applicable;
• technical documentation;
• statistical analysis;
• software or cybersecurity assessment;
• biocompatibility testing;
• electrical safety and EMC testing; and
• preparation and review of the submission.

These external costs can be substantially higher than the FDA user fee itself, depending on the device.

15.3 The 510(k) Pathway

For a device that requires a 510(k), the manufacturer generally pays a 510(k) user fee when submitting the application, unless an applicable exemption or waiver applies.

The actual amount changes by fiscal year.

A manufacturer should therefore use the FDA’s current fee schedule when preparing its project budget rather than using a historical fee found in an older publication.

The 510(k) fee is only the FDA submission fee.

The total project cost can also include the technical work required to demonstrate substantial equivalence.

For example:

Regulatory strategy → predicate identification → gap assessment → testing → technical documentation → 510(k) preparation → FDA submission

Each step can generate additional costs.

15.4 De Novo Costs

The De Novo classification process is used for certain novel devices for which there is no suitable predicate device but which are considered appropriate for classification into Class I or Class II based on the applicable criteria.

A De Novo request has its own FDA user fee.

Because the regulatory pathway is different from a traditional 510(k), the technical and regulatory preparation may also be different.

A manufacturer should therefore not assume that a De Novo request simply represents a more expensive version of a 510(k).

The regulatory strategy should be established before significant testing and submission preparation begin.

15.5 PMA Costs

The Premarket Approval (PMA) pathway generally involves significantly more extensive regulatory evidence than a typical 510(k).

The FDA user fee for a PMA is correspondingly different.

More importantly, the manufacturer’s overall project costs can be considerably higher because a PMA may require extensive:

• nonclinical testing;
• clinical evidence;
• manufacturing information;
• risk analysis;
• statistical evaluation;
• technical documentation; and
• FDA interaction.

The FDA fee therefore represents only one component of the overall PMA project cost.

15.6 Small Business Considerations

The FDA recognizes that the financial burden of user fees can be particularly significant for smaller companies.

For certain FDA user fees, a manufacturer may qualify for small business fee reductions or waivers, depending on the applicable requirements.

The FDA determines eligibility according to specific criteria, including the company’s financial information and, where applicable, the relationship between the applicant and affiliated entities.

Importantly, small-business status should not simply be assumed because a company has a small number of employees.

The manufacturer should review the FDA’s current small-business guidance and certification requirements before relying on a reduced fee.

15.7 Establishment Registration Fees

Manufacturers should also distinguish between premarket submission fees and establishment registration fees.

These are separate regulatory activities.

A company may need to pay an annual establishment registration fee when registration is subject to a fee under the applicable FDA rules.

This means that the cost structure can continue after the initial market-entry process.

A simplified example is:

Premarket submission fee → Clearance/Approval → Establishment registration and applicable annual fees → Ongoing compliance

The exact obligations depend on the establishment and its activities.

15.8 Testing Costs

Testing is often one of the largest cost components of an FDA project.

The FDA does not generally operate as a testing laboratory for manufacturers.

The manufacturer is responsible for generating the appropriate evidence to support its regulatory submission.

Depending on the device, this can include:

• electrical safety;
• EMC;
• wireless testing;
• biocompatibility;
• sterilization validation;
• packaging validation;
• software verification and validation;
• cybersecurity evaluation;
• mechanical testing;
• environmental testing;
• performance testing; and
• clinical studies.

The actual test program depends heavily on the device and its risks.

There is therefore no meaningful universal price for “FDA testing.”

15.9 Pre-Compliance Testing Can Reduce Project Costs

Pre-compliance testing can have an important economic benefit.

A problem discovered during a formal test campaign can result in:

Failure → redesign → additional engineering → repeat testing → documentation updates

A problem discovered earlier may instead result in:

Early finding → design adjustment → targeted re-test → final verification

This does not mean that pre-compliance testing eliminates the need for formal testing.

Its value is that it can help identify technical weaknesses before they become expensive project delays.

For manufacturers, the relevant question is therefore not simply how much pre-compliance testing costs, but also:

What could it cost if the problem is discovered only during the final compliance test program?

15.10 Clinical Evidence Can Change the Cost Structure Completely

For some medical devices, clinical evidence can represent a substantial portion of the overall regulatory project.

The cost can include:

• clinical study design;
• study sites;
• investigators;
• patient recruitment;
• monitoring;
• statistical analysis;
• clinical documentation; and
• regulatory management.

Whether clinical evidence is required depends heavily on the device, regulatory pathway, intended use, risk profile, and existing evidence.

It should therefore be determined as part of the regulatory strategy rather than assumed at the end of the project.

15.11 U.S. Representation and Import Costs

Foreign manufacturers can also have costs associated with their U.S. market structure.

These may include:

• U.S. Agent services;
• Initial Importer activities;
• regulatory representation;
• warehousing;
• distribution;
• customs and logistics; and
• local regulatory support.

These are not necessarily FDA user fees.

Nevertheless, they are part of the total cost of entering the U.S. market.

For a European manufacturer, this distinction is important when preparing a realistic market-entry budget.

15.12 FDA Review Delays Can Also Create Costs

The direct FDA fee is only one part of the financial risk.

Additional FDA questions or deficiencies can result in:

• additional testing;
• engineering changes;
• additional documentation;
• regulatory consulting;
• internal project work;
• delayed launch;
• additional laboratory costs; and
• postponed revenue.

This is why submission quality can have a direct economic impact.

A manufacturer should not optimize only for the lowest initial regulatory expenditure.

The more relevant objective is:

Minimize the total cost of achieving and maintaining market access.

15.13 A Realistic FDA Project Budget

A manufacturer preparing a U.S. market-entry project should consider at least the following cost categories:

Cost category	Typical relevance
Regulatory strategy	Almost always
FDA user fee	Depends on pathway
Testing	Depends heavily on device
Pre-compliance testing	Optional but potentially valuable
Clinical evidence	Device/pathway dependent
Technical documentation	Almost always
Regulatory consulting	Optional/internal capability dependent
U.S. Agent	Relevant to foreign manufacturers
Establishment registration	Where applicable
Initial Importer	Depends on distribution structure
Labeling	Almost always
Quality system	Ongoing
Postmarket compliance	Ongoing
Design changes and retesting	Risk dependent

The important point is that the FDA fee is only one line in the overall project budget.

15.14 Costs Should Be Estimated After the Regulatory Pathway Is Known

One of the most common mistakes is trying to calculate the complete FDA cost before determining the applicable regulatory pathway.

A better sequence is:

1. Define the device

↓

2. Define the Intended Use

↓

3. Determine classification

↓

4. Identify the regulatory pathway

↓

5. Identify the evidence required

↓

6. Define the testing and documentation strategy

↓

7. Calculate the total project cost

Only after these steps can the manufacturer develop a meaningful estimate.

This is particularly important for medical devices because two products that appear technically similar can have very different regulatory and testing requirements depending on their Intended Use, classification, predicate strategy and risk profile.

15.15 The Practical Takeaway

There is no universal price for obtaining FDA market access.

The total cost is determined by the combination of:

Device + Intended Use + Classification + Regulatory Pathway + Evidence Requirements + Testing + Submission + Market-Entry Structure + Ongoing Compliance

The FDA user fee is therefore only one part of the financial picture.

For manufacturers, the most effective way to control cost is to determine the regulatory strategy before committing to the full testing and documentation program.

A well-defined regulatory pathway can prevent unnecessary testing, avoid inappropriate submissions and reduce the risk of expensive redesigns and repeated testing later in the project.

16. What Happens After the FDA Submission?

Submitting a medical device application to the FDA is not the final step in the regulatory process. Once the submission has been received, the FDA reviews the information and determines whether the submitted evidence is sufficient to support the applicable regulatory decision.

The exact process depends on the regulatory pathway. A 510(k), De Novo request and PMA are not reviewed in exactly the same way.

The general principle, however, is the same:

The FDA evaluates whether the information submitted provides an adequate basis for the requested regulatory decision.

If information is missing or questions arise during the review, the manufacturer may have an opportunity to respond.

16.1 The Review Process Depends on the Regulatory Pathway

The FDA uses different premarket pathways for medical devices.

The principal pathways discussed in this guide are:

• 510(k) Premarket Notification
• De Novo Classification Request
• Premarket Approval (PMA)

Generally, a 510(k) is used where a legally marketed predicate device can support a determination of substantial equivalence. A De Novo request can provide a pathway for certain novel devices where no legally marketed predicate exists but the device can be appropriately classified as Class I or Class II. PMA is the most stringent pathway and is generally used for Class III devices requiring premarket approval.

The review process and the possible FDA decisions therefore depend on which pathway applies.

16.2 What Happens When FDA Receives the Submission?

The first stage is generally an administrative or acceptance review.

The FDA checks whether the submission contains the information necessary for the review to proceed.

This is important because:

Acceptance of a submission does not mean that FDA has agreed with the manufacturer’s regulatory conclusions.

It means that the submission has passed the applicable initial review and can proceed to substantive evaluation.

For a PMA, for example, FDA performs an acceptance and filing review before beginning the in-depth substantive review. FDA states that a PMA is considered filed when it has reached the threshold of being sufficiently complete for in-depth review.

The same basic distinction exists for other pathways: administrative acceptance is not equivalent to clearance or approval.

16.3 Substantive Review

After the initial review, FDA performs the substantive evaluation.

This is where the actual regulatory and technical content of the submission is assessed.

Depending on the device and pathway, FDA reviewers may evaluate areas such as:

• intended use;
• device classification;
• technological characteristics;
• safety;
• effectiveness;
• performance;
• risk information;
• nonclinical testing;
• clinical evidence;
• labeling;
• manufacturing information; and
• other information relevant to the specific regulatory pathway.

The FDA may also involve different specialist reviewers depending on the technology and questions raised by the submission.

For a PMA, for example, FDA describes a substantive review involving scientific, regulatory and quality-system evaluation, potentially including nonclinical and clinical studies as well as manufacturing information.

16.4 FDA May Ask for Additional Information

A manufacturer should not assume that the FDA review will simply result in a Yes or No decision.

The FDA may identify questions or deficiencies that require additional information.

For a 510(k), the FDA may use Interactive Review or issue an Additional Information (AI) Request. FDA explains that an AI Request places the submission on hold and requires the submitter to provide a complete response within the applicable timeframe.

The requested information could relate to areas such as:

• missing test information;
• clarification of the device description;
• additional technical evidence;
• clarification of the intended use;
• additional safety information;
• additional performance information;
• labeling; or
• other deficiencies identified during the review.

This is one reason why the quality of the original submission matters.

16.5 Interactive Review

The FDA can sometimes address deficiencies through Interactive Review rather than placing the submission formally on hold.

During Interactive Review, the FDA reviewer can communicate with the submitter and request additional information or clarification.

For 510(k) submissions, FDA describes Interactive Review as a process in which outstanding deficiencies can potentially be resolved within the applicable review timeframe without placing the submission on hold. Communication can occur through channels such as email or telephone.

This can make the review process more efficient, but it does not mean that the manufacturer can provide incomplete information casually.

Any requested information still needs to be prepared accurately and submitted through the applicable FDA submission process.

16.6 What Happens When FDA Issues an Additional Information Request?

An Additional Information request is more significant than a simple question from a reviewer.

For a 510(k), FDA states that the submission is placed on hold when an AI Request is issued.

The submitter generally has 180 calendar days from the date of the AI Request to provide a complete response. FDA states that no extension beyond those 180 days is granted. If a complete response is not received within that period, the 510(k) is considered withdrawn and deleted from the FDA review system, and a new 510(k) would be required to pursue clearance for the device.

This creates a practical project-management requirement:

FDA Question → Internal Assessment → Evidence Generation → Response Preparation → Submission

The manufacturer should therefore react quickly once an AI Request is received.

16.7 FDA Does Not Necessarily Expect a Completely New Submission

Receiving questions from FDA does not automatically mean that the entire regulatory strategy has failed.

In many cases, the manufacturer can address the identified issues by providing:

• clarification;
• additional documentation;
• additional test data;
• revised analysis;
• additional labeling information; or
• other requested evidence.

The appropriate response depends entirely on the deficiencies identified by FDA.

The manufacturer should therefore distinguish between:

“FDA needs more information”

and

“FDA has determined that the device cannot receive the requested authorization.”

These are not the same situation.

16.8 What Happens With a 510(k)?

The objective of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.

During the review, FDA evaluates whether the new device has the same intended use as the predicate and whether differences in technological characteristics raise different questions of safety and effectiveness.

If FDA determines that the requirements for substantial equivalence are met, the device receives a 510(k) clearance.

This is important terminology:

A 510(k) device is generally “cleared,” not “FDA approved.”

FDA itself distinguishes the 510(k) clearance process from PMA approval.

16.9 What Happens If a 510(k) Is Not Substantially Equivalent?

If FDA determines that the device is not substantially equivalent (NSE) to the predicate, the 510(k) pathway does not provide clearance.

However, an NSE outcome does not necessarily mean that the device can never enter the U.S. market.

Depending on the circumstances, the manufacturer may need to consider another regulatory pathway.

For certain novel devices, a De Novo Classification Request may be appropriate.

FDA specifically identifies a De Novo pathway for certain devices that lack a legally marketed predicate but can be appropriately classified into Class I or Class II.

The manufacturer should therefore evaluate the reason for the NSE determination before deciding what to do next.

16.10 What Happens During a De Novo Review?

A De Novo request undergoes an acceptance review followed by substantive review.

During substantive review, FDA evaluates whether the device is eligible for De Novo classification and considers the appropriate risk-based classification.

FDA may identify deficiencies that can be addressed through Interactive Review.

If the issues cannot be resolved through Interactive Review, FDA can issue an Additional Information letter requesting further information.

A successful De Novo request results in the device being classified as Class I or Class II.

Importantly, a device classified through De Novo can, where applicable, subsequently serve as a predicate device for future 510(k) submissions.

16.11 What Happens During a PMA Review?

The PMA process is more extensive.

FDA describes the PMA review as a multi-stage process including:

1. acceptance and filing review;
2. substantive scientific, regulatory and quality-system review;
3. potential advisory committee review; and
4. final FDA decision.

During the substantive review, FDA can issue deficiency letters requesting additional information.

FDA may also conduct manufacturing inspections and, where relevant, review clinical-study information.

The FDA can ultimately issue different types of decisions, including:

• Approval Order;
• Approvable Letter;
• Not Approvable Letter; or
• Order Denying Approval.

16.12 What Is an Approvable Letter?

An Approvable Letter means that FDA considers the PMA substantially sufficient for approval but requires specified additional information or conditions before approval can be granted.

The manufacturer may need to provide additional information, agree to specific conditions, complete additional actions, or satisfy other requirements identified by FDA.

The manufacturer can then respond to the issues identified by FDA.

An approvable letter therefore does not mean that the device has already been approved.

It means that FDA has identified a defined path toward approval.

16.13 What Is a Not Approvable Letter?

A Not Approvable Letter indicates that FDA believes the PMA cannot currently be approved because significant deficiencies remain.

FDA’s PMA process allows the applicant to respond to the deficiencies by amending the PMA, or the applicant can pursue other options specified by the regulations, including requesting administrative review or withdrawing the PMA.

The important practical point is:

A negative FDA decision does not always mean that the project is finished.

The manufacturer needs to understand exactly why FDA reached the decision.

16.14 Can a Manufacturer Improve the Submission and Apply Again?

Yes, in many circumstances.

The appropriate response depends on the regulatory pathway and the nature of the FDA decision.

Possible actions can include:

• providing additional information;
• correcting deficiencies;
• conducting additional testing;
• modifying the device;
• changing or clarifying labeling;
• submitting an amendment where permitted;
• pursuing a different regulatory pathway; or
• submitting a new application.

For example, if a 510(k) is deleted after the manufacturer fails to provide a complete response to an AI Request within the required 180-day period, FDA states that the manufacturer must submit a new 510(k) if it wants to pursue clearance.

For a PMA, FDA explicitly provides mechanisms for responding to deficiencies through amendments and other regulatory procedures.

The correct strategy therefore depends on the specific FDA decision rather than simply “applying again.”

16.15 Why a Rejection Should Be Analyzed Before Re-Submission

A manufacturer should avoid immediately repeating the same submission after an unsuccessful review.

The first question should be:

Why did FDA not accept or clear/approve the device?

Possible causes can be very different.

For example:

Missing evidence

→ Additional evidence may solve the problem.

Insufficient test data

→ Additional or revised testing may be required.

Problem with the predicate strategy

→ Another predicate or regulatory pathway may need to be considered.

Different technological characteristics

→ Additional safety/effectiveness evidence may be necessary.

Unclear Intended Use

→ The regulatory strategy and labeling may need to be reassessed.

Fundamental safety/effectiveness concern

→ Significant design or clinical changes may be necessary.

A successful response therefore starts with understanding the regulatory deficiency rather than simply adding more documents.

16.16 Pre-Submission Interaction Can Reduce This Risk

Manufacturers do not always have to wait until the formal submission to communicate with FDA.

The FDA offers the Q-Submission Program, which provides mechanisms for sponsors to request feedback and meetings regarding certain medical device submissions.

The purpose is to obtain FDA feedback on specific questions before submitting the corresponding marketing application.

This can be particularly valuable when there is uncertainty about:

• regulatory strategy;
• testing;
• clinical evidence;
• predicate selection;
• study design;
• submission content; or
• other important regulatory questions.

The objective is not to obtain a preliminary approval.

Rather, it is to obtain FDA feedback that can help the manufacturer prepare a more appropriate submission.

16.17 The FDA Review Is an Interaction, Not Just a Waiting Period

A common misconception is that submitting the application means:

Submit → Wait → FDA Decision

In reality, the process can be much more interactive:

Submission → Acceptance Review → Substantive Review → Questions → Manufacturer Response → Further Review → Decision

The manufacturer therefore needs resources available during the FDA review, not just before submission.

This includes regulatory expertise, technical experts and potentially testing resources.

16.18 The Practical Takeaway

An FDA submission should not be considered a one-way application.

The review process can involve several rounds of communication and requests for additional information.

The manufacturer should therefore prepare for three possible scenarios:

Scenario 1 — Straightforward review

Submission → Review → Clearance/Approval

Scenario 2 — Additional information required

Submission → Review → FDA Questions → Response → Continued Review → Clearance/Approval

Scenario 3 — Regulatory strategy needs to change

Submission → FDA Decision/Deficiency → Root-Cause Analysis → Additional Evidence, Design Change or Different Regulatory Pathway → New or Amended Submission

The most important lesson is that an unsuccessful FDA review is not automatically the end of the project.

What matters is understanding the reason for the FDA’s decision and determining whether the identified issues can be addressed through additional evidence, changes to the device or documentation, an amendment, or a different regulatory pathway.

17. FDA Registration, Listing and the Role of the U.S. Agent

Once the appropriate premarket requirements have been fulfilled, foreign manufacturers need to consider another important part of entering the U.S. market: establishment registration, device listing and the role of the U.S. Agent.

These requirements are separate from the premarket submission itself.

A manufacturer can therefore have a device that has received the required FDA clearance or approval and still have additional registration and listing obligations before legally marketing it in the United States.

17.1 Registration and Listing Are Not the Same as FDA Clearance or Approval

It is important to distinguish between three different concepts:

Premarket authorization

→ Determines whether the device may be marketed through the applicable regulatory pathway.

Establishment registration

→ Identifies the establishment involved in the manufacture or other regulated activity.

Device listing

→ Identifies the medical devices associated with the registered establishment.

These are separate regulatory requirements.

Registration or listing does not mean that FDA has evaluated or approved the safety or effectiveness of the listed device.

Similarly, registering an establishment does not replace a required 510(k), De Novo request or PMA.

17.2 Who Must Register?

The FDA requires establishments involved in the manufacture, preparation, propagation, compounding or processing of medical devices for commercial distribution in the United States to register, subject to the applicable exemptions and specific regulatory requirements.

The FDA maintains a detailed list of establishments that are required to register under 21 CFR Part 807.

This can include foreign manufacturers.

For a European manufacturer selling a medical device into the United States, the foreign manufacturing establishment will therefore generally have FDA registration obligations.

However, the exact registration requirements depend on the activities performed by the establishment.

17.3 What Is Device Listing?

In addition to establishment registration, manufacturers generally need to list the medical devices they manufacture or process.

Device listing provides FDA with information about the products associated with a registered establishment.

The listing process is therefore different from a premarket submission.

For example:

510(k) clearance

does not itself replace

Establishment Registration + Device Listing

where those requirements apply.

The FDA explains that establishments required to register must also provide information about the devices they manufacture or process through the device-listing process.

17.4 When Does Registration Take Place?

Registration and listing generally occur in connection with the establishment beginning the relevant regulated activity.

The timing depends on the establishment and the activity involved.

Manufacturers should therefore not treat registration as something that can simply be completed at any time after commercial distribution has already started.

The FDA provides specific registration and listing requirements and deadlines under its regulations and guidance.

The manufacturer’s regulatory plan should include these activities as part of the overall U.S. market-entry process.

17.5 Annual Registration

Registration is not simply a one-time activity.

For establishments subject to registration, the FDA requires registration information to be reviewed and updated according to the applicable requirements.

The FDA’s annual registration process includes confirming or updating establishment information and device listings.

This means that manufacturers need an internal process for keeping their FDA registration information current.

Changes to information such as:

• establishment details;
• ownership;
• manufacturing activities;
• device listings; or
• other relevant information

may require updates.

The exact requirements depend on the type of establishment and the change involved.

17.6 The U.S. Agent for Foreign Manufacturers

A foreign manufacturer that is required to register with FDA must generally designate a U.S. Agent.

The U.S. Agent must have a physical address in the United States.

The U.S. Agent is not simply a mailing address.

The FDA defines specific responsibilities for the U.S. Agent, including acting as a point of contact between FDA and the foreign establishment.

This makes the U.S. Agent an important part of the regulatory structure for foreign manufacturers.

17.7 What Does the U.S. Agent Do?

The U.S. Agent has several regulatory responsibilities.

Among other things, the U.S. Agent can:

• assist FDA in communicating with the foreign manufacturer;
• respond to FDA questions concerning the foreign establishment;
• assist with scheduling inspections;
• receive communications from FDA on behalf of the foreign manufacturer; and
• provide information to FDA as required under the applicable regulations.

The FDA explicitly states that the U.S. Agent must be available to respond to FDA communications and assist the agency with matters concerning the foreign establishment.

The U.S. Agent therefore acts as a regulatory communication link.

17.8 What the U.S. Agent Does Not Do

The U.S. Agent should not be confused with a distributor, importer or regulatory consultant.

The U.S. Agent does not automatically:

• manufacture the device;
• test the device;
• obtain FDA clearance;
• approve the product;
• take over the manufacturer’s Quality Management System;
• become the legal manufacturer; or
• automatically assume responsibility for the manufacturer’s regulatory compliance.

The foreign manufacturer remains responsible for complying with the applicable FDA requirements.

A U.S. Agent is therefore primarily a regulatory contact and communication function, not a replacement for the manufacturer’s own regulatory responsibilities.

17.9 U.S. Agent vs. Initial Importer

These roles are particularly easy to confuse.

A U.S. Agent represents the foreign establishment for specified FDA communication purposes.

An Initial Importer, by contrast, is involved in bringing a foreign-manufactured device into the United States and has specific responsibilities under the FDA regulations.

The same company can potentially have multiple roles, but the roles themselves are not identical.

For example:

European Manufacturer

→ U.S. Agent

→ Initial Importer

→ Distributor

These can be three different entities.

The manufacturer should therefore define the U.S. market structure clearly before beginning commercial distribution.

17.10 Device Listing Does Not Mean the FDA Has Approved the Device

This distinction deserves particular attention because FDA registration databases are publicly searchable.

A company may appear in FDA databases as a registered establishment and have devices listed.

That does not automatically mean that the device has received FDA clearance or approval.

Likewise, the appearance of a company in an FDA registration database should not be interpreted as an FDA endorsement of the company or its products.

Premarket authorization and registration/listing serve different regulatory purposes.

17.11 What Information Is Required?

The information required for registration and listing depends on the establishment and the applicable regulatory requirements.

Typical information can include:

• establishment identification;
• contact information;
• manufacturer information;
• U.S. Agent information for foreign establishments;
• device information;
• applicable product codes;
• manufacturing activities; and
• other information required by FDA.

The FDA provides registration and listing instructions and identifies the information establishments need to submit.

The manufacturer should therefore collect the necessary information before starting the registration process rather than attempting to determine the required information during submission.

17.12 FDA Registration Through FURLS

FDA establishment registration and device listing are handled electronically through the FDA’s registration and listing systems.

The FDA uses its FURLS (FDA Unified Registration and Listing System) environment for medical device registration and listing activities.

Manufacturers should use the current FDA instructions because the specific electronic process and requirements can change.

17.13 Is FDA Registration the Same as FDA Approval?

No.

This is one of the most important distinctions for manufacturers.

Consider the following example:

A manufacturer has:

FDA Establishment Registration

but no required 510(k).

The registration does not give the manufacturer permission to market a device that legally requires a 510(k).

Likewise:

510(k) Clearance

without completing applicable registration and listing requirements does not mean that all market-entry obligations have been fulfilled.

Both parts need to be considered separately.

17.14 What Happens If Registration or Listing Is Incorrect?

FDA registration and listing information needs to remain accurate.

If a manufacturer provides incorrect information or fails to update information when required, this can create regulatory problems.

For example, the manufacturer may need to update:

• establishment information;
• U.S. Agent information;
• device listings;
• manufacturing activities; or
• other registration information.

The exact update requirements depend on the change.

A manufacturer should therefore assign responsibility internally for maintaining FDA registration and listing information.

17.15 What a Foreign Manufacturer Should Plan Before Market Entry

For a foreign medical device manufacturer, the market-entry sequence can be simplified as follows:

1. Determine the applicable regulatory pathway

↓

2. Complete the required premarket process

↓

3. Establish the U.S. market structure

↓

4. Appoint a U.S. Agent

↓

5. Complete establishment registration

↓

6. Complete device listing

↓

7. Establish the applicable importer/distribution structure

↓

8. Begin commercial distribution

The exact sequence can vary depending on the product and business structure, so it should be checked against the applicable FDA requirements before launch.

17.16 The Practical Takeaway

For a foreign manufacturer, FDA market access does not consist solely of obtaining a 510(k) clearance, De Novo classification or PMA approval.

The manufacturer must also establish the appropriate regulatory infrastructure for operating in the United States.

The most important distinction is:

Premarket authorization answers whether the device can be marketed under the applicable regulatory pathway. Registration and listing identify the regulated establishment and its devices.

For foreign manufacturers, the U.S. Agent adds another important element by providing the FDA with a U.S.-based regulatory contact.

These activities should therefore be planned as part of the overall U.S. market-entry strategy rather than treated as administrative tasks after the regulatory project is finished.

18. Quality Management and Post-Market Compliance

Obtaining FDA clearance, De Novo classification, or PMA approval does not mark the end of a medical device manufacturer’s regulatory obligations.

FDA compliance continues throughout the entire product lifecycle. Once a device is manufactured and commercially distributed in the United States, the manufacturer must continue to meet applicable requirements relating to its quality management system, complaint handling, medical device reporting, corrective actions, recalls, recordkeeping, and other post-market activities.

This is an important distinction for manufacturers familiar with the European CE-marking process. FDA market access should not be understood as a single regulatory event followed by unrestricted market access.

The regulatory obligations continue after the device reaches the market.

18.1 FDA Compliance Is a Lifecycle Process

The FDA regulatory framework covers the medical device throughout its lifecycle.

A simplified view is:

Product Development
↓
Regulatory Strategy
↓
Premarket Submission
↓
Clearance / De Novo Classification / Approval
↓
Manufacturing
↓
Commercial Distribution
↓
Complaints & Post-Market Monitoring
↓
Reporting / Corrective Actions / Recalls
↓
Ongoing Compliance and Change Assessment

The FDA’s post-market framework includes activities such as monitoring device performance, reporting certain adverse events and malfunctions, maintaining applicable registration and listing information, conducting required post-market surveillance, and taking corrective action where necessary.

The practical consequence is straightforward:

FDA compliance is not completed when the product receives market authorization.

It becomes an ongoing responsibility.

18.2 The Quality Management System Regulation (QMSR)

One of the most important continuing FDA obligations concerns the manufacturer’s Quality Management System (QMS).

The regulatory framework changed significantly on February 2, 2026, when the FDA’s Quality Management System Regulation (QMSR) became effective.

The QMSR amended 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, together with the applicable definitions in Clause 3 of ISO 9000:2015. The objective is to align the FDA’s medical-device quality requirements more closely with the internationally recognized ISO 13485 framework.

For manufacturers already operating an ISO 13485-based quality management system, this creates greater familiarity between their existing quality framework and the FDA requirements.

However, an important distinction remains:

ISO 13485 certification does not automatically mean that a manufacturer is compliant with every FDA requirement.

The QMSR is a U.S. federal regulatory requirement. Manufacturers must therefore assess their own activities against the applicable FDA requirements rather than assuming that an existing ISO 13485 certificate alone establishes FDA compliance.

18.3 Who Is Subject to the QMSR?

The QMSR applies to manufacturers of finished devices that are intended for commercial distribution in the United States.

The FDA’s concept of a finished device is broader than simply the company performing final assembly. Certain accessories and other products can also fall within the regulatory definition depending on their role.

Manufacturers should therefore determine whether their activities fall within the scope of the QMSR based on the applicable regulatory definitions rather than assuming that the regulation applies only to companies that manufacture the complete finished product themselves.

The practical question is not simply:

“Do we have an ISO 13485 certificate?”

It is:

“Does our organization and our manufacturing activity fall within the scope of the QMSR, and are our processes compliant with the applicable requirements?”

18.4 What Does the Quality Management System Cover?

A medical device QMS is intended to ensure that the manufacturer’s processes consistently produce devices that meet applicable requirements.

Depending on the manufacturer and the products involved, the QMS can encompass areas such as:

• management responsibility;
• organizational responsibilities;
• design and development;
• risk-related activities;
• purchasing;
• supplier controls;
• production;
• process controls;
• identification and traceability;
• equipment and infrastructure;
• complaint handling;
• records and documentation;
• monitoring and measurement;
• nonconforming product;
• corrective action;
• quality-related investigations;
• process and product controls.

The exact requirements depend on the manufacturer’s activities, products, and applicable regulatory obligations.

The incorporation of ISO 13485 into the QMSR provides the central quality-management framework, but manufacturers must still understand how the requirements apply to their specific organization.

18.5 QMSR and Premarket Submissions Are Not the Same Thing

An important distinction is often overlooked:

Having a QMS is not the same as submitting the entire QMS to the FDA as part of a premarket application.

The amount of manufacturing and quality-system information required in a particular premarket submission depends on the device and the applicable regulatory pathway.

The QMSR, on the other hand, establishes continuing regulatory obligations for manufacturers within its scope.

This means a manufacturer should think about two related but different questions:

Premarket question:
What quality, manufacturing, and process information must be provided to support this particular FDA submission?

Ongoing compliance question:
Does our quality system meet the requirements that apply to our organization and products?

Confusing these two concepts can lead either to unnecessary documentation in the submission or, more seriously, to an inadequate quality system after market entry.

18.6 FDA Inspections

FDA compliance is not assessed exclusively through documents submitted during a premarket review.

The FDA can inspect medical device establishments to determine whether they comply with applicable regulatory requirements.

This is particularly important under the QMSR because the FDA changed its inspection approach when the regulation became effective on February 2, 2026.

The FDA replaced the previous Quality System Inspection Technique (QSIT) approach with the updated inspection program Compliance Program 7382.850 for assessing compliance with the QMSR.

During an inspection, FDA investigators may evaluate relevant:

• quality-system processes;
• procedures;
• records;
• manufacturing activities;
• complaint handling;
• corrective actions;
• design and production controls;
• supplier controls; and
• other evidence of compliance.

The FDA has also stated that investigators may review certain records created before the QMSR became effective when assessing current compliance.

For manufacturers, this means that compliance cannot be demonstrated merely by having written procedures. The organization must be able to demonstrate that its processes are actually implemented and controlled.

18.7 Complaint Handling

Once a medical device is commercially distributed, the manufacturer needs an effective process for receiving and evaluating complaints.

A complaint can involve an alleged deficiency related to:

• identity;
• quality;
• durability;
• reliability;
• safety;
• effectiveness; or
• performance of the device.

Complaint handling is therefore not simply a customer-service function.

A complaint may trigger a regulatory assessment and potentially additional actions.

A simplified process can look like:

Customer Complaint
↓
Internal Evaluation
↓
Is the event potentially reportable?
↓
MDR Assessment
↓
Investigation / Corrective Action if necessary

The manufacturer needs a documented process for receiving, evaluating, investigating where appropriate, and maintaining complaint records.

Complaint handling should also be connected to the manufacturer’s broader quality system so that recurring problems can be identified and addressed rather than treated as isolated customer-service cases.

18.8 Medical Device Reporting (MDR)

The FDA operates a mandatory Medical Device Reporting (MDR) system under 21 CFR Part 803.

Manufacturers and importers must report certain device-related events to the FDA.

For manufacturers, reportable events generally include:

• deaths;
• serious injuries; and
• certain malfunctions.

The standard reporting period is generally 30 calendar days from the date the manufacturer or importer becomes aware of information that reasonably suggests that a reportable event has occurred.

Certain events require faster reporting. FDA rules provide for 5-day reports in specified circumstances, including certain events requiring remedial action to prevent an unreasonable risk of substantial harm to the public health.

Manufacturers therefore need a process capable of determining:

1. what happened;
2. whether the device may be involved;
3. whether the event meets the applicable reporting criteria;
4. when the manufacturer became aware of the relevant information; and
5. whether an MDR must be submitted.

18.9 An MDR Report Does Not Automatically Mean the Device Caused the Event

An important distinction is that submitting an MDR does not by itself establish that the medical device caused the reported event.

The MDR system is intended to provide the FDA with information about potentially reportable device-related events.

Manufacturers should therefore distinguish between:

• reporting an event because it meets the applicable reporting criteria; and
• establishing the ultimate technical or medical cause of the event.

The manufacturer may need to conduct additional investigation to determine the cause and whether corrective action is required.

18.10 Corrective Actions and CAPA

When a manufacturer identifies a product or process problem, it must determine what action is appropriate.

Depending on the circumstances, this can include:

• investigation of the underlying problem;
• correction of the affected product;
• containment;
• corrective action;
• changes to manufacturing processes;
• changes to suppliers or components;
• additional testing;
• changes to labeling or instructions;
• design changes; or
• other measures to prevent recurrence.

Within the quality system, such activities need to be controlled and documented appropriately.

The important principle is that a manufacturer should not simply correct the individual defective product while ignoring the underlying process or systemic issue.

Where appropriate, the manufacturer needs to determine why the problem occurred and whether similar problems could affect other products or batches.

18.11 Corrections and Removals

A manufacturer may sometimes need to correct or remove a device that has already entered commercial distribution.

Examples can include situations involving:

• a safety-related defect;
• incorrect labeling;
• a manufacturing problem;
• a software issue;
• a performance problem;
• contamination; or
• another condition that requires action on products already distributed.

Depending on the circumstances, the manufacturer may need to notify customers, distributors, healthcare facilities, or the FDA.

The regulatory requirements depend on the nature and significance of the action.

Manufacturers should therefore have procedures that allow them to determine whether a field action constitutes a reportable correction or removal and what notifications are required.

18.12 Recalls

A recall is a specific type of corrective action involving a marketed device that violates FDA requirements and requires action to remove the violation or reduce a risk.

Recalls can be initiated voluntarily by a manufacturer or required by FDA under applicable circumstances.

A recall process can involve:

• identifying affected products;
• determining the scope of the affected distribution;
• communicating with customers or distributors;
• retrieving or correcting affected products;
• documenting the action;
• evaluating its effectiveness; and
• communicating with FDA where required.

The manufacturer must be able to trace relevant products and maintain the records necessary to manage such an action effectively.

18.13 Post-Market Surveillance

For certain devices and circumstances, the FDA can require additional post-market surveillance.

Post-market surveillance is intended to collect information about the safety and performance of a device after it has entered commercial distribution.

Depending on the device and regulatory requirements, this can involve:

• monitoring complaints;
• analyzing adverse events;
• reviewing product performance;
• identifying trends;
• conducting required surveillance studies; and
• evaluating whether additional regulatory or corrective action is necessary.

Not every device is subject to a formal post-market surveillance study.

The manufacturer should therefore distinguish between its general obligation to monitor and evaluate device performance and a specific FDA requirement to conduct a formal post-market surveillance program.

18.14 Trend Analysis and Early Detection

Effective post-market compliance is not limited to reacting to individual complaints.

Manufacturers should also evaluate information for recurring patterns and trends.

For example, a series of individually minor complaints may collectively indicate:

• a design problem;
• a manufacturing process issue;
• a supplier problem;
• a software defect;
• inadequate labeling; or
• another systemic issue.

A functioning quality system should allow such information to flow between:

Complaints → Quality → Engineering → Risk Management → Regulatory Affairs

This is particularly important for complex medical devices where a problem identified after market introduction may require reassessment of the original risk analysis or technical documentation.

18.15 Changes to a Marketed Device

A device does not remain regulatorily unchanged simply because its original FDA clearance or approval remains valid.

Manufacturers routinely make changes to:

• hardware;
• components;
• materials;
• suppliers;
• manufacturing processes;
• software;
• cybersecurity;
• packaging;
• labeling;
• intended use; or
• production locations.

Before implementing a change, the manufacturer should determine whether the change affects the device’s existing FDA regulatory status.

Depending on the nature of the change, this may require:

• internal documentation and assessment only;
• additional verification or validation;
• updated risk analysis;
• new or additional testing;
• updated labeling;
• a new or supplemental FDA submission; or
• another regulatory action.

The important principle is:

Do not assume that a change is regulatory-neutral. Assess it before implementation.

This is particularly important for 510(k)-cleared devices, where certain changes may require a new 510(k), depending on whether the modification could significantly affect safety or effectiveness.

18.16 Recordkeeping and Traceability

Post-market compliance depends heavily on reliable records.

Manufacturers may need to maintain records relating to:

• production;
• quality activities;
• complaints;
• investigations;
• MDR assessments;
• corrective actions;
• recalls;
• device distribution;
• changes;
• testing;
• suppliers; and
• other regulated activities.

The precise recordkeeping requirements depend on the applicable FDA regulations and the manufacturer’s activities.

Good traceability is particularly important when a manufacturer needs to determine:

Which products were affected, where were they distributed, and what action is necessary?

Without adequate records, even a technically correct corrective action can become difficult or impossible to execute effectively.

18.17 What Happens When a Manufacturer Fails to Maintain Compliance?

FDA compliance failures can have consequences beyond a single defective product.

Depending on the circumstances, FDA action can involve:

• requests for corrective action;
• inspection findings;
• warning letters;
• import-related actions;
• recalls;
• seizure;
• injunction;
• civil or criminal enforcement actions; or
• other regulatory measures.

The specific consequences depend on the nature and severity of the violation.

For manufacturers, the most effective strategy is therefore not to treat FDA compliance as an exercise in responding to FDA after a problem occurs.

The objective should be to identify and control regulatory risks before they become enforcement problems.

18.18 The Practical Compliance Model

A practical way to understand FDA post-market compliance is to view it as a continuous feedback loop:

Manufacturing
↓
Marketed Device
↓
Complaints / Performance Data / Adverse Events
↓
Evaluation
↓
MDR / Investigation / Trend Analysis
↓
Corrective Action if Required
↓
Risk Management / Design / Manufacturing / Labeling Updates
↓
Continued Market Monitoring

This feedback loop connects the quality system with regulatory affairs, engineering, manufacturing, and post-market surveillance.

It also explains why FDA compliance cannot be managed as a one-time certification project.

18.19 The Practical Takeaway

For a medical device manufacturer, FDA market access is only one stage of a much longer regulatory lifecycle.

The manufacturer must be prepared to:

• maintain an applicable Quality Management System;
• comply with the QMSR;
• manage complaints;
• evaluate potentially reportable events;
• submit MDRs where required;
• investigate product and process problems;
• implement corrective actions;
• manage corrections and removals;
• conduct recalls where necessary;
• maintain appropriate records;
• monitor device performance;
• assess changes before implementation; and
• maintain ongoing regulatory compliance.

The key distinction is:

FDA clearance or approval gives the manufacturer the applicable regulatory authorization to market the device. It does not remove the manufacturer’s continuing responsibility for the device once it is on the market.

For manufacturers entering the U.S. market, this lifecycle perspective is essential. The regulatory strategy should therefore connect product development, testing, quality management, manufacturing, regulatory affairs, and post-market activities rather than treating them as independent processes.

Official FDA sources

• FDA – Quality Management System Regulation (QMSR)
• FDA – Medical Device Reporting (MDR)
• FDA – Recalls, Corrections and Removals (Devices)
• FDA – Postmarket Surveillance Program
• FDA – Quality System Inspection Technique (QSIT) / QMSR Inspection Program

19. FDA Fees and Costs for Medical Devices

FDA market access involves more than the cost of preparing and submitting a regulatory application. Depending on the product and the manufacturer’s situation, costs can arise from premarket submissions, establishment registration, annual establishment fees, clinical studies, testing, consultants, U.S. representation, and post-market obligations.

There is therefore no single fixed price for obtaining FDA market access.

The actual cost depends heavily on the regulatory pathway, device classification, submission type, company size, clinical evidence requirements, and the amount of work required to prepare the submission.

19.1 FDA Fees Are Not the Same for Every Medical Device

The FDA charges user fees for certain medical device activities under the Medical Device User Fee Amendments (MDUFA).

The fee structure is updated periodically.

For the current fiscal year, manufacturers should therefore always check the FDA’s current fee schedule rather than relying on historical figures.

The FDA publishes the applicable medical device user fees and fee amounts on its official website.

Typical fee categories can include:

• 510(k) submissions;
• De Novo classification requests;
• PMA submissions;
• PMA supplements;
• establishment registration; and
• other specified regulatory activities.

The amount depends on the specific submission or activity.

19.2 Small Businesses Can Qualify for Reduced Fees

One of the most important cost considerations is the FDA’s Small Business Determination (SBD).

Certain small businesses can qualify for substantially reduced FDA user fees.

However, the manufacturer does not automatically receive reduced fees simply because it considers itself a small company.

The company must meet the FDA’s applicable eligibility requirements and obtain the appropriate Small Business Determination.

The FDA publishes specific criteria and procedures for determining whether a business qualifies.

This can make a significant difference in the total cost of a regulatory project.

19.3 A Small Business Determination Is Not the Same as FDA Registration

These two concepts should not be confused.

FDA Establishment Registration

→ identifies a regulated establishment.

Small Business Determination

→ determines whether a company qualifies for certain reduced FDA user fees.

A manufacturer may therefore need to deal with both, but they serve completely different purposes.

The Small Business Determination is essentially a fee-status determination.

19.4 The Cost of a 510(k)

A 510(k) is generally less expensive from an FDA user-fee perspective than a PMA.

However, the FDA fee is only one component of the total project cost.

A manufacturer may also need to pay for:

• regulatory strategy;
• preparation of the submission;
• testing;
• laboratory services;
• technical documentation;
• biocompatibility testing;
• software or cybersecurity evidence where relevant;
• clinical evidence where required;
• labeling;
• consultant support; and
• responses to FDA questions.

The total project cost can therefore be significantly higher than the FDA submission fee itself.

19.5 The Cost of a De Novo Submission

A De Novo Classification Request has its own FDA user fee.

Because De Novo is intended for certain novel devices without an appropriate predicate, the regulatory and technical work can also be more extensive than for a straightforward 510(k).

The manufacturer may need to establish an appropriate risk-based classification and demonstrate that the device can reasonably be controlled through general and, where applicable, special controls.

Consequently, the cost of a De Novo project depends heavily on the evidence required for the particular device.

The FDA publishes separate fee categories for De Novo requests.

19.6 The Cost of a PMA

A Premarket Approval (PMA) is generally the most demanding of the principal FDA premarket pathways discussed in this guide.

The FDA user fee for a PMA is correspondingly much higher than for a 510(k).

More importantly, the FDA fee is often only a small part of the overall PMA project cost.

A PMA may involve:

• extensive nonclinical testing;
• clinical studies;
• statistical analysis;
• manufacturing information;
• quality-system activities;
• specialist regulatory support;
• FDA interactions;
• inspections; and
• long-term post-approval obligations.

For a manufacturer considering a PMA pathway, the cost of the regulatory evidence can therefore be far greater than the FDA application fee itself.

The FDA’s current user-fee schedule should always be checked before budgeting a PMA project.

19.7 Establishment Registration Fees

FDA establishment registration also involves fees in applicable cases.

The registration fee is separate from a 510(k), De Novo or PMA user fee.

This creates an important distinction:

Premarket submission fee

≠

Establishment registration fee

A manufacturer may therefore encounter multiple FDA fees during the market-entry process.

The FDA publishes the current establishment-registration fee as part of its annual medical device user-fee schedule.

19.8 The FDA Fee Is Only One Part of the Budget

A realistic FDA project budget should therefore not be structured simply as:

FDA Fee = Total FDA Cost

A better model is:

FDA User Fees

•  

Regulatory Preparation

•  

Testing

•  

Clinical Evidence, if required

•  

Documentation

•  

Consulting / Regulatory Support

•  

U.S. Agent

•  

Registration & Listing

•  

Post-Market Compliance

=

Total U.S. Regulatory Cost

This distinction is particularly important when comparing FDA market access with other regulatory systems.

19.9 Testing Costs

Testing can become one of the largest cost components.

The type and extent of testing depend on the medical device.

Potential areas can include:

• electrical safety;
• EMC;
• wireless/radio testing where applicable;
• biocompatibility;
• mechanical safety;
• software verification;
• cybersecurity;
• sterilization;
• packaging;
• environmental testing; and
• performance testing.

Not every device requires all of these.

The correct testing strategy must be derived from the device characteristics, intended use, applicable standards, risks and regulatory pathway.

This is why testing should be planned before the FDA submission is prepared.

19.10 Clinical Evidence Can Change the Budget Completely

Clinical evidence can have a particularly large effect on project costs.

Some devices may be supported primarily through existing information and nonclinical evidence.

Others may require clinical data.

If a clinical investigation is necessary, costs can include:

• study design;
• investigators;
• clinical sites;
• patient recruitment;
• monitoring;
• data management;
• statistical analysis;
• ethics and regulatory activities; and
• study documentation.

The difference between a submission that can rely largely on existing evidence and one requiring a new clinical investigation can therefore be substantial.

For this reason, the question:

“Will we need clinical data?”

should be addressed as early as possible in the regulatory strategy.

19.11 The Cost of FDA Questions

FDA questions can also create additional costs.

If the FDA requests additional information, the manufacturer may need to perform:

• additional testing;
• additional analysis;
• new technical documentation;
• revised labeling;
• additional clinical analysis; or
• regulatory consulting.

A submission that appears inexpensive initially can therefore become considerably more expensive if the evidence strategy was incomplete.

This is one reason why a strong submission strategy before filing can reduce overall project risk.

19.12 U.S. Agent Costs

Foreign manufacturers generally need a U.S. Agent when registration is required.

The U.S. Agent is usually provided as a commercial service and therefore creates an additional business cost.

The FDA itself does not set a universal commercial price for U.S. Agent services.

Pricing depends on the provider and the scope of the service.

Possible service models include:

• basic regulatory representation;
• registration support;
• FDA communication support;
• complaint-related support; or
• broader regulatory representation.

The manufacturer should therefore evaluate exactly what the contracted U.S. Agent service includes.

19.13 Regulatory Consultant Costs

Many manufacturers use external regulatory specialists, particularly when entering the U.S. market for the first time.

Consultants can support areas such as:

• classification;
• regulatory pathway selection;
• predicate strategy;
• submission preparation;
• testing strategy;
• FDA communication;
• clinical strategy;
• QMS implementation; and
• post-market compliance.

Consultant costs are not FDA fees and are not standardized.

They can vary considerably depending on:

• product complexity;
• regulatory pathway;
• project scope;
• consultant experience; and
• amount of work required.

19.14 A Useful Way to Think About FDA Project Costs

Instead of asking:

“How much does FDA approval cost?”

manufacturers should ask:

“What evidence and regulatory activities will this particular device require to legally enter and remain on the U.S. market?”

That question leads to a much more realistic budget.

For example:

Lower-complexity scenario

510(k)

• limited additional testing
• existing technical documentation
• straightforward QMS

→ relatively contained project.

More complex scenario

510(k)

• extensive testing
• software/cybersecurity evidence
• additional FDA questions
• significant submission work

→ substantially higher project cost.

High-complexity scenario

PMA

• clinical study
• extensive nonclinical evidence
• manufacturing/QMS work
• FDA interactions
• post-approval obligations

→ potentially a major multi-year regulatory investment.

The FDA fee itself does not reflect this difference.

19.15 Fees Can Change

FDA user fees are periodically revised.

Manufacturers should therefore avoid using an old fee table when preparing a current project budget.

The FDA publishes the applicable fees for each fiscal year.

For a real submission, the manufacturer should verify:

• the current fiscal year;
• the exact submission type;
• whether a Small Business Determination applies;
• whether the relevant fee is paid before submission; and
• whether additional fees apply to the planned regulatory activities.

The official FDA fee schedule should always be treated as the authoritative source for the actual amount.

19.16 Building a Realistic FDA Budget

A practical budget should therefore be divided into several categories:

Cost category	Typical examples
FDA fees	510(k), De Novo, PMA, registration
Regulatory work	Strategy, classification, submission preparation
Testing	Safety, EMC, performance, biocompatibility, etc.
Clinical	Studies and clinical evidence where required
Documentation	Technical and regulatory documentation
External support	Consultants and specialists
U.S. market structure	U.S. Agent, importer-related costs
QMS	Implementation, maintenance and audits
Post-market	Complaint handling, MDR, surveillance, recalls if necessary

Not every project requires every category.

The purpose of the structure is to ensure that manufacturers do not mistake the FDA user fee for the total cost of FDA market access.

19.17 The Practical Takeaway

There is no meaningful universal answer to:

“How much does FDA approval cost?”

The answer depends primarily on the device, regulatory pathway and evidence required.

A useful budgeting principle is:

The FDA fee is only one component of the cost of U.S. market access.

For a relatively straightforward device using the 510(k) pathway, the submission fee may be only one part of a larger testing and regulatory project.

For a PMA device, clinical evidence and other technical and regulatory activities can dominate the total budget.

Manufacturers should therefore determine the regulatory pathway and evidence strategy first, and calculate the total project cost afterward.

The FDA’s current official user-fee schedule should always be checked immediately before budgeting or submitting, because the applicable fees can change from one fiscal year to another.

20. What Happens if the FDA Does Not Clear or Approve the Device?

An unfavorable FDA decision does not necessarily mean that the product can never enter the U.S. market.

The consequences depend on the regulatory pathway, the reason for the FDA’s decision, and whether the deficiencies can be addressed.

In many cases, the manufacturer can provide additional information, amend the submission, submit a new application, or pursue a different regulatory pathway.

The important point is that a negative FDA decision should first be understood as a regulatory outcome that needs to be analyzed, rather than simply as a final failure.

20.1 A Negative FDA Decision Can Have Different Meanings

Not every negative outcome means the same thing.

There is an important difference between:

• a submission that is incomplete;
• a submission that is placed on hold;
• a 510(k) that receives an NSE (Not Substantially Equivalent) decision;
• a De Novo request that is declined;
• a PMA that receives a Not Approvable decision; and
• a PMA that is formally denied.

The available options can be very different in each situation.

The first step should therefore always be to understand why FDA did not accept, clear or approve the submission.

20.2 A 510(k) Can Receive an NSE Decision

For a 510(k), the FDA determines whether the new device is Substantially Equivalent (SE) to a legally marketed predicate device.

If the FDA determines that the device is not substantially equivalent, the result is an NSE – Not Substantially Equivalent decision.

The device cannot be marketed under that 510(k).

An NSE decision does not necessarily mean that the device itself is unsafe.

It may, for example, result from:

• an unsuitable predicate;
• an inappropriate intended use comparison;
• technological differences that raise different questions of safety or effectiveness;
• insufficient performance information; or
• another issue preventing FDA from finding substantial equivalence.

The FDA’s 510(k) guidance specifically recognizes several possible reasons for an NSE decision.

20.3 What Can a Manufacturer Do After an NSE?

An NSE does not necessarily end the project.

The FDA identifies several possible paths after an NSE decision.

Depending on the circumstances, the manufacturer may:

1. Submit another 510(k) with additional or different information;
2. Pursue a De Novo Classification Request;
3. Submit a reclassification petition; or
4. Pursue a PMA, where appropriate.

The appropriate option depends on the reason for the NSE and the characteristics of the device.

For example, if the fundamental problem was the absence of an appropriate predicate and the device is suitable for De Novo classification, a De Novo pathway may be more appropriate than trying to force the device into another 510(k).

20.4 Improving the Product or Improving the Submission?

This distinction is extremely important.

An unfavorable FDA decision does not automatically mean:

“The product itself must be redesigned.”

Sometimes the problem is the evidence rather than the product.

For example, FDA may determine that the submitted information does not adequately demonstrate performance or substantial equivalence.

In such a case, additional:

• testing;
• analysis;
• technical documentation;
• clinical information; or
• comparison with the predicate

may address the problem.

In other cases, however, FDA may identify a genuine issue with the device’s design, intended use, labeling or risk profile.

The manufacturer must therefore distinguish between:

Regulatory / Evidence Problem

and

Product / Safety / Performance Problem

before deciding what to change.

20.5 A New 510(k) Can Be Submitted

If the deficiencies can be addressed, the manufacturer can submit another 510(k) containing the necessary information.

The new submission should not simply repeat the unsuccessful application.

The manufacturer should first determine:

• Why was the previous submission unsuccessful?
• Which FDA concerns must be addressed?
• Is the predicate still appropriate?
• Is the intended use correctly defined?
• Are the technological characteristics adequately compared?
• Is additional testing necessary?
• Is clinical evidence required?
• Does the product remain suitable for the 510(k) pathway?

The FDA explicitly recognizes resubmission with new data as one possible response to an NSE decision.

20.6 De Novo Can Be an Alternative

A particularly important alternative after an NSE is the De Novo pathway.

De Novo is intended for certain novel devices for which there is no legally marketed predicate device, but where general controls alone or general and special controls can provide reasonable assurance of safety and effectiveness.

This can be particularly relevant when the manufacturer initially attempted a 510(k), but FDA determined that no appropriate predicate exists.

If the De Novo request is granted:

• the device is classified;
• a new classification regulation is established; and
• the device may subsequently serve as a predicate for certain future 510(k) submissions.

Thus, an unsuccessful 510(k) does not necessarily mean that the product has reached a dead end.

It may instead reveal that the wrong regulatory pathway was selected.

20.7 What Happens if a De Novo Request Is Declined?

A De Novo request can also be unsuccessful.

The FDA may decline a De Novo request if, for example:

• general controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness;
• the submitted information is insufficient to make that determination; or
• the probable benefits do not outweigh the probable risks.

If FDA declines the De Novo request, the device remains Class III and cannot legally be marketed on the basis of that De Novo request.

The FDA issues a written decision identifying the reasons for the decline.

The FDA states that the requester will generally need either to:

• pursue a PMA; or
• collect additional information addressing the deficiencies and submit a new De Novo request.

Again, the appropriate response depends on the reason for the decision.

20.8 What Happens to a PMA?

The PMA process provides several possible FDA outcomes.

After review, FDA may issue:

• an Approval Order;
• an Approvable Letter;
• a Not Approvable Letter; or
• an Order Denying Approval.

These outcomes should not be treated as interchangeable.

For example, an Approvable Letter indicates that FDA considers the PMA potentially approvable if specified conditions or deficiencies are addressed.

20.9 An Approvable Letter Does Not Necessarily Mean Failure

If FDA issues an Approvable Letter, the manufacturer can respond to the identified requirements.

The FDA explains that the applicant may:

• amend the PMA as requested;
• treat the letter as a denial and request administrative review; or
• withdraw the PMA.

This means the manufacturer may have an opportunity to address the identified deficiencies without starting the entire PMA process from the beginning.

20.10 A Not Approvable Letter

A Not Approvable Letter means that FDA believes the PMA cannot currently be approved for one or more specified reasons, or that there is insufficient information to reach an approvable decision.

The FDA will describe the deficiencies and, where practical, identify what is necessary to make the PMA approvable.

The applicant may then:

• amend the PMA;
• request administrative review; or
• withdraw the PMA.

Therefore, even a Not Approvable Letter does not necessarily mean that the product can never receive FDA approval.

20.11 Formal Denial of a PMA

A formal PMA denial is more serious.

FDA may deny approval if the statutory or regulatory grounds for denial apply.

The FDA’s denial order identifies the deficiencies and, where practical, the measures that could be necessary to place the PMA into approvable form.

The order also provides an opportunity to request administrative review.

A manufacturer should therefore carefully analyze the FDA’s stated grounds for denial before deciding whether to:

• correct the deficiencies;
• submit additional information through the appropriate procedure;
• request reconsideration; or
• pursue another regulatory strategy.

20.12 Can the Manufacturer Appeal an FDA Decision?

In certain circumstances, FDA decisions can be subject to administrative review or reconsideration.

The exact procedure depends on the type of decision.

For example, the PMA regulations provide specific procedures for requesting reconsideration of certain FDA decisions.

This is not equivalent to a simple commercial appeal process.

The manufacturer must follow the applicable FDA procedure and deadlines.

For a significant regulatory decision, specialized FDA regulatory counsel may therefore be appropriate.

20.13 What About a Submission That Is Not Accepted for Review?

A negative outcome can also occur before substantive FDA review.

For example, a 510(k) can be placed on RTA Hold (Refuse to Accept) if it does not meet the minimum requirements for acceptance.

This is fundamentally different from an NSE decision.

The FDA gives the submitter an opportunity to address the deficiencies. For a 510(k) placed on RTA Hold, the submitter generally has 180 calendar days to resolve the identified deficiencies. If this is not done, the submission is considered withdrawn and deleted, and a new complete 510(k) must be submitted to pursue clearance.

Therefore:

RTA

does not mean:

FDA determined that the device is not substantially equivalent.

It means the submission did not meet the requirements to proceed to substantive review.

20.14 Additional Information Requests Are Different Again

During FDA review, the agency may request additional information.

This is a normal part of the review process and should not automatically be interpreted as a rejection.

The manufacturer may need to provide:

• additional test results;
• clarifications;
• revised documentation;
• additional technical information; or
• other requested evidence.

The key issue is whether the manufacturer can adequately address the FDA’s questions within the applicable process and deadlines.

A well-managed submission therefore includes a process for responding to FDA questions quickly and consistently.

20.15 Can the Product Be Marketed While the Issue Is Being Resolved?

Generally, no.

If the required premarket authorization has not been obtained, the manufacturer cannot simply market the device in the United States while working on the deficiencies.

For a 510(k), FDA states that the device cannot be marketed until FDA issues a determination of substantial equivalence, unless another applicable legal basis permits marketing.

The same basic principle applies to products that require another form of premarket authorization.

The manufacturer must therefore distinguish between:

Regulatory work continuing

and

Legal authorization to market.

These are not the same thing.

20.16 Should the Manufacturer Change the Product Immediately?

Not necessarily.

An unfavorable FDA decision should first trigger a root-cause analysis.

A useful sequence is:

FDA Decision

↓

Identify Exact Deficiencies

↓

Classify the Problem

→ Evidence?

→ Testing?

→ Predicate?

→ Intended Use?

→ Labeling?

→ Risk?

→ Product Design?

↓

Define Corrective Strategy

↓

Determine Regulatory Consequence

↓

Submit / Resubmit / Change Pathway

Only after this analysis should the manufacturer decide whether the physical product needs to be changed.

This can prevent unnecessary redesigns.

20.17 A Negative Decision Can Actually Reveal a Strategy Problem

In some projects, the fundamental problem is not the quality of the product but the regulatory strategy used to bring it to the FDA.

For example:

A manufacturer assumes:

“There must be a predicate, so we will use a 510(k).”

But the FDA determines that the identified predicate is not appropriate.

The manufacturer may then need to reconsider whether the product should instead follow the De Novo pathway.

Similarly, a manufacturer may underestimate the evidence needed to support a particular intended use.

This is why the regulatory pathway should be assessed before significant testing and submission work begins.

20.18 A Practical Decision Tree

A simplified decision process after an unfavorable FDA outcome can look like this:

FDA does not clear / approve the device

↓

What was the reason?

Administrative / Submission Deficiency

→ Correct the submission
→ Respond within the applicable deadline

Insufficient Evidence

→ Generate additional data
→ Amend or resubmit

No Suitable Predicate

→ Evaluate De Novo

Product Risk Too High

→ Reassess design, risk controls and evidence

Regulatory Pathway Not Appropriate

→ Evaluate alternative pathway

PMA Deficiency

→ Amend PMA / reconsideration / other appropriate action

The actual options depend on the FDA decision and applicable regulations.

20.19 The Importance of Preparing for Failure Before Submission

Manufacturers often focus entirely on the question:

“How do we get FDA clearance?”

A better strategy is also to define in advance:

“What will we do if FDA disagrees with our regulatory strategy?”

Before submission, the manufacturer should therefore understand:

• the main regulatory assumptions;
• the critical evidence;
• the potential weaknesses;
• the predicate strategy, if applicable;
• the alternative regulatory pathways;
• the likely additional testing requirements; and
• the consequences of an unfavorable FDA decision.

This does not mean planning for failure.

It means ensuring that an unfavorable decision does not automatically destroy the entire project.

20.20 The Practical Takeaway

An FDA decision that prevents immediate market access is not always the end of the project.

Depending on the pathway and reason for the decision, a manufacturer may be able to:

• provide additional information;
• amend the submission;
• perform additional testing;
• improve the product;
• submit a new 510(k);
• pursue De Novo;
• pursue PMA;
• request administrative review; or
• reconsider the regulatory strategy.

The critical first step is to understand why FDA did not accept, clear or approve the device.

The FDA’s own procedures explicitly provide several routes for addressing deficiencies or pursuing an alternative pathway.

The central principle is therefore:

An unfavorable FDA decision should first be treated as a regulatory problem to analyze—not automatically as a product failure.

The sooner the manufacturer understands the exact reason for the decision, the easier it is to determine whether the right response is additional evidence, a product change, a new submission, a different regulatory pathway, or formal reconsideration.

21. The FDA Submission: Submission, Review and Decision Process

Once the classification, regulatory pathway, evidence strategy, testing and technical documentation have been prepared, the next step is the actual FDA submission.

However, submitting an application is not simply a matter of sending documents to the FDA. Depending on the submission type, the application goes through several stages before the FDA reaches a final decision.

The exact process differs particularly between 510(k), De Novo and PMA submissions.

21.1 Where Is the Submission Filed?

For many medical devices, submissions are made electronically using FDA-designated systems and submission templates.

A central role is now played by eSTAR (electronic Submission Template and Resource).

For 510(k) and De Novo submissions to CDRH or CBER, use of eSTAR is generally mandatory, subject to applicable exceptions. For PMAs, use of eSTAR is currently voluntary.

eSTAR guides the applicant through the required information and allows the relevant documents and attachments to be assembled in a standardized format.

This is important because an FDA submission is not simply an arbitrary collection of technical documents.

21.2 What Happens Immediately After Submission?

After receiving a submission, the FDA first determines whether it meets the basic requirements for further processing.

This initial review is not the same as the full scientific or technical review.

In simplified form, the process can be represented as:

Submission

↓

Administrative / Acceptance Review

↓

Substantive Review

↓

FDA Questions / Additional Information

↓

Final Decision

The exact process depends on the submission type.

21.3 The 510(k) Process

For a 510(k), the FDA initially conducts an Acceptance Review.

The FDA checks whether the submission contains the minimum information necessary to proceed to the substantive review.

The FDA generally communicates the outcome of this Acceptance Review within 15 days of receipt.

Possible outcomes include:

• the 510(k) is accepted for Substantive Review;
• the submission receives an RTA Hold (Refuse to Accept); or
• the FDA does not complete the Acceptance Review within the applicable timeframe, in which case the submission may proceed to Substantive Review.

21.4 What Does RTA Mean?

RTA stands for Refuse to Accept.

An RTA does not mean that the FDA has determined that the device is unsafe or that it is not substantially equivalent to the predicate.

Instead, it means that the submission does not meet the minimum requirements necessary for acceptance into the substantive review process.

The manufacturer receives a list of deficiencies.

For a 510(k), the applicant generally has 180 calendar days to address the identified deficiencies. If the deficiencies are not fully addressed within that period, the submission is considered withdrawn and deleted from the FDA system. A new, complete 510(k) must then be submitted for further review.

This is one reason why a thorough submission review before filing is so important.

21.5 The Substantive Review

Once a 510(k) has been accepted, the FDA begins the actual Substantive Review.

The FDA evaluates the regulatory and technical information contained in the submission.

The central question is:

Is the new device Substantially Equivalent to an appropriate Predicate Device?

The FDA evaluates factors including the Intended Use and technological characteristics of the new device.

The FDA may also assess the submitted performance data and other supporting evidence.

If questions remain, the FDA may request additional information.

21.6 How Long Does a 510(k) Review Take?

Under the current MDUFA V program, the FDA has a goal of completing a 510(k) review within 90 days.

This should not be interpreted as a guarantee that a device will be cleared within 90 calendar days.

If the FDA requests additional information and the submission is placed on hold, the FDA review clock generally stops while the applicant prepares its response.

The actual calendar time for a project can therefore be considerably longer than the FDA’s review target.

Manufacturers should distinguish between:

FDA Review Time

and

Total Project Time

21.7 The FDA May Request Additional Information

During the review, the FDA may ask the manufacturer to provide additional information.

Questions may concern, for example:

• test methods;
• test results;
• technological differences from the predicate;
• software;
• cybersecurity;
• biocompatibility;
• performance;
• labeling;
• clinical information; or
• other aspects of the submission.

The manufacturer must respond within the applicable FDA process and timeframe.

An FDA question is therefore not automatically a negative decision.

It is normally part of the review process.

21.8 What Happens After the Manufacturer Responds?

Once the manufacturer submits the requested information, the FDA continues its review.

The additional information is evaluated together with the material already submitted.

Ultimately, the FDA determines whether the available information supports the applicable regulatory requirements.

For a 510(k), this may result in a determination of Substantial Equivalence and therefore FDA clearance.

21.9 How Does a 510(k) Review End?

The objective of a successful 510(k) is a determination that the device is Substantially Equivalent to the predicate device.

If the FDA makes this determination, the device is cleared.

This terminology is important.

A 510(k) device is not technically “FDA approved.”

The FDA distinguishes between the different premarket pathways. A 510(k) results in clearance, whereas a PMA results in approval.

This distinction should also be respected in marketing and product documentation.

21.10 The De Novo Process

The basic process for a De Novo submission is similar:

Submission

↓

Acceptance Review

↓

Substantive Review

↓

FDA Questions / Additional Information

↓

FDA Decision

The regulatory question, however, is different.

A De Novo request is intended for certain novel devices for which there is no suitable predicate device, but for which General Controls and, where appropriate, Special Controls can provide reasonable assurance of safety and effectiveness.

If the FDA grants the De Novo request, the device is classified accordingly.

21.11 How Long Does a De Novo Review Take?

Under the current MDUFA V program, the FDA has a goal of reviewing a De Novo request within 150 days.

Again, this is a review goal rather than a guaranteed total project duration.

Requests for additional information and other interactions can extend the actual calendar time required.

21.12 The PMA Process Is More Extensive

The Premarket Approval (PMA) process is the most stringent of the principal FDA premarket pathways for medical devices.

The FDA describes the PMA review as a multi-stage process that can include:

1. Administrative and Filing Review
2. Detailed scientific and regulatory review
3. Advisory Panel review, where appropriate
4. Final FDA decision

A PMA does not rely on a substantial-equivalence determination.

Instead, the FDA must determine, based on sufficient scientific evidence, that the device is safe and effective for its intended use.

21.13 The Filing Review for a PMA

After receiving a PMA, the FDA first determines whether the application is sufficiently complete to enter the detailed review process.

Within 45 days after receiving the application, the FDA generally informs the applicant whether the PMA has been accepted for filing.

This distinction is important:

Filed

does not mean:

Approved

It means that the PMA has passed the initial threshold and can proceed into the detailed review.

21.14 What Happens During the PMA Review?

During the PMA review, the FDA may evaluate areas including:

• non-clinical studies;
• clinical studies;
• biocompatibility;
• engineering;
• manufacturing;
• quality systems;
• labeling;
• statistical analyses; and
• other safety and effectiveness evidence.

Depending on the device, FDA inspections of manufacturing facilities and audits of clinical study data may also be relevant.

This broad scope explains why PMA projects can be substantially more complex than many 510(k) projects.

21.15 Advisory Panel Review

For certain PMAs, the FDA may involve an Advisory Panel consisting of external experts.

The panel evaluates the relevant scientific and regulatory questions and provides recommendations to the FDA.

The panel’s recommendation is not automatically the final FDA decision.

The FDA considers the recommendation together with the other available evidence and makes the final regulatory decision.

Not every PMA is necessarily referred to an Advisory Panel.

21.16 How Long Does a PMA Review Take?

For a PMA, the statutory review period is generally 180 days from the filing date.

However, the actual process can be more complex and may be affected by amendments, requests for additional information and other interactions during the review.

The filing date is therefore important.

The 180-day period does not simply begin when the manufacturer sends the application. It is tied to the FDA’s acceptance of the PMA for filing.

21.17 The FDA May Place a Submission on Hold

During the review, the FDA may determine that additional information is necessary.

The submission may then be placed on hold while the manufacturer prepares the requested response.

This is another reason why FDA review targets should not be interpreted as guaranteed project timelines.

For example:

90-day 510(k) review goal

plus

FDA questions

plus

manufacturer response time

plus

additional testing, if required

plus

possible amendments

can result in a substantially longer overall project.

21.18 The FDA Decision

At the end of the applicable review process, the FDA issues its decision.

The terminology depends on the regulatory pathway:

Pathway	Successful outcome
510(k)	Cleared
De Novo	Granted / Classified
PMA	Approved

These terms should be used correctly in regulatory and commercial communications.

In particular, a 510(k)-cleared device should not simply be advertised as an “FDA approved” device.

21.19 An FDA Submission Is a Dialogue

An important point is often overlooked:

An FDA submission is not necessarily a one-time exchange of documents.

The process can instead be viewed as a dialogue:

Manufacturer

→ Submission

FDA

→ Questions / Requests

Manufacturer

→ Additional Information

FDA

→ Further Review

Manufacturer

→ Amendments / Clarifications

FDA

→ Decision

Manufacturers should therefore plan sufficient resources to respond to FDA questions quickly and consistently.

21.20 Why Preparation Is So Important

The FDA is not simply checking whether the manufacturer has submitted a large number of documents.

The key question is whether the submission provides a clear and scientifically and regulatorily coherent argument.

A strong submission should therefore establish a logical connection between:

Intended Use

↓

Classification / Regulatory Pathway

↓

Risks

↓

Regulatory Requirements

↓

Testing / Clinical Evidence

↓

Safety & Performance

↓

Labeling

↓

FDA Submission

When this chain is consistent, the FDA can more readily understand the manufacturer’s regulatory rationale.

21.21 The Key Point for Manufacturers

The FDA submission should not be the point at which the regulatory concept of a device is being developed for the first time.

By the time the submission is filed, the manufacturer should already understand:

• what the device is;
• which FDA requirements apply;
• which regulatory pathway is being used;
• what evidence is required;
• which tests have been performed;
• why those tests are relevant;
• which risks have been addressed; and
• how the evidence supports safety and effectiveness or substantial equivalence.

Ideally, the FDA review should confirm that the regulatory strategy is sound rather than reveal that fundamental elements are missing.

A successful FDA submission therefore begins long before the actual filing date.

The FDA provides specific procedures, templates and review processes for the different submission types. These requirements should always be checked against the current FDA guidance before an actual submission, as electronic submission procedures and regulatory requirements can change.

22. What Happens After FDA Clearance or Approval?

Receiving FDA clearance or approval is a major milestone, but it is not the end of the FDA compliance process.

For many manufacturers, the next steps are just as important as the pre-market submission itself. Before a device can actually be placed on the U.S. market, the manufacturer may still need to complete establishment registration, device listing, U.S. Agent arrangements, importer requirements and other applicable obligations.

These requirements are separate from the pre-market decision.

22.1 FDA Clearance or Approval Is Not the Same as Registration

One of the most common misunderstandings is the belief that an FDA-cleared or FDA-approved device is automatically fully registered for commercial distribution.

That is not necessarily the case.

The FDA distinguishes between:

• Premarket clearance or approval
• Establishment registration
• Device listing
• U.S. Agent designation
• Importer registration

These are separate regulatory steps.

The FDA explicitly states that registration and listing do not mean that a facility or device has been approved, cleared or otherwise authorized by the FDA.

Conversely, obtaining a 510(k) clearance or PMA approval does not by itself complete all registration and listing obligations.

22.2 Establishment Registration

Companies involved in the production and distribution of medical devices intended for the U.S. market are generally required to register their establishments with the FDA.

This is known as Establishment Registration and is governed principally by 21 CFR Part 807.

Depending on the company’s role, registration requirements can apply to establishments such as:

• manufacturers;
• contract manufacturers;
• contract sterilizers;
• specification developers;
• repackers and relabelers;
• initial importers; and
• certain other establishments involved in the commercial distribution of devices.

The exact obligation depends on the activity performed by the establishment.

22.3 Foreign Manufacturers Have Additional Requirements

For a manufacturer located outside the United States, additional requirements apply.

A foreign establishment manufacturing a device for import into the United States generally must:

1. Register the establishment;
2. List the applicable devices;
3. Identify a U.S. Agent; and
4. comply with the applicable FDA requirements for foreign establishments.

The foreign manufacturer must register before exporting the device to the United States.

This means that a European manufacturer cannot simply obtain FDA clearance and immediately begin exporting the product without completing the applicable establishment and listing requirements.

22.4 What Is the U.S. Agent?

A foreign establishment that manufactures, prepares, propagates, compounds or processes a device imported into the United States must designate a U.S. Agent.

The U.S. Agent must:

• reside in the United States or maintain a place of business there;
• have a physical U.S. address;
• be available to communicate with the FDA; and
• formally accept the role.

A foreign establishment may designate only one U.S. Agent.

The U.S. Agent serves primarily as a communication link between the FDA and the foreign establishment.

22.5 What Does the U.S. Agent Actually Do?

The role of the U.S. Agent is sometimes misunderstood.

The U.S. Agent can assist the FDA by:

• communicating with the foreign manufacturer;
• responding to FDA questions concerning imported devices;
• assisting with scheduling FDA inspections; and
• receiving FDA communications or documents when the FDA cannot directly contact the foreign establishment promptly.

The U.S. Agent is not automatically responsible for the manufacturer’s entire FDA compliance program.

The FDA specifically states that the U.S. Agent does not have responsibility for:

• Medical Device Reporting; or
• submitting 510(k) Premarket Notifications.

Therefore, appointing a U.S. Agent does not transfer the manufacturer’s regulatory responsibilities to that agent.

22.6 Device Listing

Registration of the establishment is only one part of the process.

The applicable devices must also be listed with the FDA.

Generally, establishments that are required to register are also required to list the devices they manufacture and identify the activities performed on those devices.

If the device required a premarket submission, the applicable premarket submission number is generally included as part of the listing information.

Depending on the situation, this may be a:

• 510(k) number;
• De Novo number;
• PMA number;
• PDP number; or
• HDE number.

22.7 Registration and Listing Are Electronic

FDA registration and listing information is generally submitted electronically through the FDA’s FURLS / Device Registration and Listing Module (DRLM).

The FDA requires establishments to submit the information electronically unless an appropriate waiver has been granted.

The registration process involves the FDA’s Device Facility User Fee (DFUF) system and FURLS/DRLM.

The manufacturer first obtains the required payment identification information and then uses the resulting confirmation information when completing the registration.

22.8 When Must Registration Take Place?

For an establishment that is required to register, the timing depends on the activity being performed.

For a foreign manufacturer, FDA registration must generally be completed before exporting devices to the United States.

For establishments beginning an applicable activity or placing a device into commercial distribution, the FDA generally requires registration and/or listing within the applicable 30-day period.

Importantly, when a device requires premarket notification clearance or approval, the manufacturer generally must wait until the applicable premarket submission has been cleared or approved before completing the registration and listing associated with that device.

22.9 Annual Registration

FDA establishment registration is not generally a one-time event.

Required establishments must renew their registration every year.

The FDA specifies an annual registration period from:

October 1 – December 31

During this period, establishments must review their registration and listing information and submit any required updates.

This means that obtaining FDA clearance or approval does not remove the manufacturer from ongoing FDA administrative obligations.

22.10 Registration Fees

Most establishments that are required to register must also pay an annual FDA establishment registration fee.

For Fiscal Year 2026, the standard annual establishment registration fee is:

$11,423 per establishment.

The FDA also provides reduced fees for qualifying small businesses under the applicable Small Business Determination program.

These fees are separate from premarket application fees.

For example, for FY 2026, the FDA lists the following standard application fees:

Submission	FY 2026 standard fee
510(k)	$26,067
De Novo	$173,782
PMA	$579,272

Qualifying small businesses may pay substantially reduced fees.

Because FDA user fees are periodically adjusted, manufacturers should always verify the current fee schedule before submitting an application or registering an establishment.

22.11 Registration Does Not Mean FDA Approval

This distinction is so important that it deserves to be stated again.

A company may appear in the FDA registration database without the FDA having approved or cleared its products.

Likewise, a company may advertise itself as:

“FDA Registered”

without this meaning that its device is FDA approved.

The FDA explicitly warns that terms such as:

• FDA Registered;
• FDA Certified;
• FDA Registration Certificate

should not be interpreted as evidence that a device has been FDA approved or cleared.

Manufacturers should therefore use FDA terminology carefully in marketing materials.

For example:

510(k) cleared

is fundamentally different from:

FDA registered

and both are different from:

FDA approved.

22.12 What About the U.S. Importer?

The supply chain must also be considered.

A foreign manufacturer may sell its device through a U.S. importer or distributor.

An Initial Importer is an establishment that facilitates the import of a device into the United States and is responsible for certain FDA requirements associated with that role.

The manufacturer and importer therefore need to establish clearly:

• who manufactures the device;
• who owns the device;
• who imports it;
• who distributes it;
• who is responsible for complaints;
• who maintains the relevant records; and
• who communicates with the FDA when required.

These responsibilities should be defined before commercial distribution begins.

22.13 Changes After Registration Must Be Maintained

FDA registration and listing information is not static.

The FDA allows establishments to update their information throughout the year.

Changes can include, for example:

• adding a new device;
• changing where a device is manufactured;
• removing a device from commercial distribution;
• resuming distribution of a previously discontinued device;
• changing establishment information; or
• changing the U.S. Agent.

The FDA requires establishments to keep their registration and listing information current.

This is particularly important for manufacturers with several production sites or contract manufacturers.

22.14 The U.S. Agent Must Also Be Maintained

The U.S. Agent is not simply a name that is entered once into the FDA database.

If the relationship with the U.S. Agent changes, the manufacturer must update the relevant FDA information.

The FDA also requires the designated U.S. Agent to confirm acceptance of the role.

If the proposed agent does not confirm the appointment within the FDA’s process, the foreign establishment must designate another U.S. Agent.

A foreign manufacturer should therefore have a clear contractual and operational relationship with its U.S. Agent.

22.15 What Happens if the Manufacturer Has Several Facilities?

The FDA registration system works at the establishment level.

A manufacturer with:

• a manufacturing site in Germany;
• a sterilization site in France;
• a contract manufacturing site in Italy; and
• a U.S. importer

may therefore have several establishments with different regulatory roles.

Each establishment must be assessed individually to determine:

• whether registration is required;
• whether device listing is required;
• whether a fee applies;
• what activity must be identified; and
• whether a U.S. Agent is required.

The manufacturer should not assume that registering the corporate headquarters automatically covers every facility involved in manufacturing or distribution.

22.16 What Happens After the Device Is Actually on the Market?

FDA compliance continues after commercial launch.

Depending on the product and regulatory pathway, manufacturers may have ongoing obligations relating to:

• Medical Device Reporting (MDR);
• complaint handling;
• corrections and removals;
• recalls;
• quality systems;
• post-market surveillance;
• reporting obligations;
• changes to the device;
• labeling changes; and
• maintenance of registration and listing information.

The exact obligations depend on the device, its classification and the applicable regulations.

This is why FDA compliance should be viewed as a product lifecycle process, rather than a single approval event.

22.17 A Practical Example

Consider a German manufacturer developing an electrically powered medical device for the U.S. market.

The manufacturer:

1. Determines that the product is a Medical Device

↓

2. Identifies the applicable Product Code and Classification

↓

3. Determines that a 510(k) is required

↓

4. Identifies a suitable Predicate Device

↓

5. Performs the required testing

↓

6. Submits the 510(k)

↓

7. Receives FDA clearance

At this point, the manufacturer has achieved an important regulatory milestone.

But the process is not necessarily complete.

The manufacturer may then need to:

8. Register the applicable establishment

↓

9. List the device

↓

10. Identify a U.S. Agent if the manufacturer is foreign

↓

11. Ensure the applicable importer is properly registered

↓

12. Complete the applicable commercial distribution requirements

↓

13. Maintain ongoing FDA compliance

Only then does the complete market-access process come together.

22.18 The Key Distinction

The U.S. market access process can therefore be understood as several separate regulatory layers:

Stage	Main question
Classification	What type of device is this?
Premarket pathway	What must be demonstrated before marketing?
FDA decision	Has the applicable premarket requirement been satisfied?
Registration & Listing	Which establishments and devices are registered with FDA?
Import / Distribution	Who brings the device into the U.S. and distributes it?
Post-Market Compliance	What obligations continue after launch?

A manufacturer that focuses only on the first three stages can still encounter problems when trying to actually commercialize the product.

22.19 The Practical Takeaway

For a foreign medical device manufacturer, FDA clearance or approval is not the final administrative step before entering the U.S. market.

The manufacturer should also establish:

• which establishments must register;
• which devices must be listed;
• whether a U.S. Agent is required;
• who acts as the importer;
• which fees apply;
• when registration must be completed;
• how registration and listing will be maintained; and
• which post-market obligations apply.

The FDA’s registration and listing requirements are separate from the premarket decision, and the FDA explicitly warns that registration should never be presented as evidence of FDA approval or clearance.

FDA clearance or approval gives the manufacturer the necessary regulatory market-access decision for the applicable pathway. Registration, listing, importation and ongoing compliance complete the broader regulatory framework required to commercialize and maintain the device on the U.S. market.

Official FDA sources

• FDA – Device Registration and Listing
• FDA – U.S. Agents
• FDA – Who Must Register, List and Pay the Fee
• FDA – When to Register and List
• FDA – Medical Device User Fee Amendments (MDUFA): Fees
• FDA – Are There “FDA Registered” or “FDA Certified” Medical Devices?

23. What Happens If the FDA Does Not Clear or Approve the Device?

Not every FDA submission ends with a positive decision.

A submission may be refused for filing, placed on hold, receive a request for additional information, or ultimately result in a Not Substantially Equivalent (NSE) decision for a 510(k), a declined De Novo request, or a denial of a PMA.

However, an unfavorable FDA decision does not necessarily mean that the product can never enter the U.S. market.

The appropriate response depends on why the FDA did not accept, clear or approve the submission and on the regulatory pathway involved.

23.1 An Unfavorable FDA Decision Is Not Always the End

There is an important distinction between different types of negative outcomes.

A manufacturer may receive:

• an RTA (Refuse to Accept);
• an FDA request for additional information;
• an NSE (Not Substantially Equivalent) decision for a 510(k);
• a Decline of a De Novo request;
• a Not Approvable letter for a PMA;
• or a formal Denial of a PMA.

These outcomes have different regulatory consequences and different options for the manufacturer.

The first step should therefore always be to understand exactly why the FDA reached the particular decision.

23.2 RTA Is Not a Rejection of the Device

An RTA – Refuse to Accept occurs when a submission does not meet the FDA’s minimum requirements for acceptance.

This is different from a substantive determination that the device is unsafe or unsuitable for the intended market.

For a 510(k), for example, an RTA means that the FDA has identified deficiencies that prevent the submission from entering the substantive review process.

The manufacturer can address the identified deficiencies and proceed according to the applicable FDA process.

This is why an RTA should not automatically be interpreted as:

“The FDA rejected our device.”

The FDA has essentially determined that the submission, in its current form, is not ready for substantive review.

23.3 What If the FDA Finds a 510(k) Not Substantially Equivalent?

A more significant situation occurs when the FDA completes the substantive review of a 510(k) and determines that the device is Not Substantially Equivalent (NSE).

This means that the FDA has not found the necessary substantial equivalence between the new device and the claimed predicate.

The FDA may reach an NSE determination for several reasons.

For example:

• an appropriate predicate device was not identified;
• the intended use is not sufficiently comparable;
• technological differences raise different questions of safety or effectiveness;
• the submitted performance data do not adequately address those differences; or
• the available evidence does not establish substantial equivalence.

The FDA explicitly states that an NSE determination can result from issues involving the predicate, intended use, technological characteristics or supporting performance information.

23.4 Can a Manufacturer Apply Again After an NSE?

Yes.

An NSE decision does not necessarily mean that the manufacturer must abandon the product.

The FDA explicitly identifies several possible routes following an NSE determination.

Depending on the circumstances, the manufacturer may:

1. Submit another 510(k) with new data;
2. pursue a De Novo Classification Request;
3. submit a reclassification petition; or
4. submit a PMA, where appropriate.

The appropriate option depends on the reason for the NSE decision.

This is an important practical point:

A failed 510(k) does not automatically mean that the device cannot be marketed in the United States.

It may instead indicate that the chosen regulatory pathway or supporting evidence needs to be reconsidered.

23.5 Improving the 510(k) Before Resubmission

If the problem is insufficient evidence, the manufacturer may be able to address the FDA’s concerns through additional work.

For example, the manufacturer may need to:

• perform additional testing;
• provide more complete performance data;
• clarify the intended use;
• address differences from the predicate;
• provide additional software documentation;
• provide additional biocompatibility evidence;
• improve the substantial-equivalence comparison; or
• provide additional clinical or non-clinical evidence where appropriate.

The FDA’s 510(k) requirements specifically emphasize that the submission must provide sufficient information for the FDA to determine substantial equivalence.

The correct response is therefore not simply to submit the same application again.

The manufacturer should first identify which part of the regulatory argument failed.

23.6 The Predicate Device May Be the Problem

One particularly important issue in a 510(k) is the choice of predicate device.

The manufacturer may have selected a device that initially appeared comparable but does not provide an adequate basis for the substantial-equivalence argument.

For example, the devices may have:

• different intended uses;
• different indications;
• technological differences that raise new questions of safety or effectiveness; or
• other characteristics that prevent the required equivalence determination.

The FDA’s guidance on classification and product codes emphasizes the importance of considering intended use, indications and technological characteristics when identifying an appropriate predicate.

In such a case, simply adding more test reports to the existing strategy may not solve the underlying problem.

The regulatory strategy itself may need to change.

23.7 Could the Device Need a De Novo Submission Instead?

In some cases, an NSE decision indicates that the device does not fit appropriately into the 510(k) framework because there is no suitable predicate.

A De Novo Classification Request may then be an appropriate alternative.

De Novo is specifically intended to provide a pathway for certain novel device types that do not have an appropriate predicate but for which General Controls, or General and Special Controls, can provide reasonable assurance of safety and effectiveness.

This can therefore turn an apparent regulatory dead end into a different regulatory pathway.

23.8 What Happens If a De Novo Request Is Declined?

A De Novo request can also be declined.

The FDA may decline a De Novo request if, for example:

• General Controls or General and Special Controls are insufficient;
• the submitted information is insufficient to determine whether those controls can provide reasonable assurance of safety and effectiveness; or
• the probable benefits do not outweigh the probable risks.

If the De Novo request is declined, the device remains in Class III and cannot legally be marketed on the basis of that De Novo request.

The FDA states that the requester may generally either:

• collect additional information and submit a new De Novo request, or
• pursue a PMA, where appropriate.

Again, the FDA’s reasons for the decision are critical in determining what should happen next.

23.9 A Declined De Novo Does Not Necessarily Mean the Product Is Impossible

A De Novo decline may indicate that the FDA does not currently have sufficient evidence to establish an appropriate risk-based classification.

For example, the manufacturer may need to generate additional:

• performance data;
• safety information;
• clinical evidence;
• risk-control information; or
• information supporting the proposed General and Special Controls.

The manufacturer can then reassess whether the deficiencies can be addressed through additional evidence.

The goal should not be to simply produce more documentation.

The goal is to provide the specific evidence necessary to resolve the FDA’s concerns.

23.10 What Happens If a PMA Is Not Approved?

The PMA process is different because it requires an independent demonstration of safety and effectiveness.

The FDA can issue an Approvable Letter or a Not Approvable Letter during the review process.

A Not Approvable Letter identifies the deficiencies that prevent approval and, where practical, describes what would be necessary to bring the PMA into approvable form.

The manufacturer may then:

• amend the PMA as requested;
• consider the letter a denial and request administrative review; or
• withdraw the PMA.

23.11 Can a PMA Be Resubmitted?

Yes.

The FDA explicitly allows a PMA that has been withdrawn, refused for filing or disapproved to be resubmitted.

A resubmitted PMA must comply with the applicable PMA requirements and must reference the original PMA number and explain the reason for the resubmission.

This means that a PMA denial does not necessarily close the regulatory pathway permanently.

The manufacturer can address the deficiencies and submit the application again.

23.12 The Difference Between Withdrawal and Denial

These terms should not be confused.

A manufacturer may withdraw a submission voluntarily.

A denial, on the other hand, is an FDA decision that the application does not meet the applicable requirements.

For PMAs, the FDA also has specific procedures for amendments, withdrawal, resubmission and administrative review.

This distinction can matter for the regulatory history of the product and for determining the appropriate next step.

23.13 Can the Manufacturer Appeal an FDA Decision?

In certain circumstances, yes.

The available review or appeal mechanisms depend on the type of FDA decision and the applicable regulation.

For example, in the PMA process, the FDA provides an opportunity for administrative review following a denial. The applicant may file a petition for reconsideration under the applicable procedures.

However, an appeal should not automatically be the first response.

If the FDA has identified substantive scientific or technical deficiencies, it may be more effective to understand those deficiencies and determine whether they can be resolved through additional evidence or a revised submission.

23.14 What Should a Manufacturer Do After an Unfavorable Decision?

The manufacturer should avoid immediately submitting another application without analyzing the previous one.

A structured review should begin with the FDA’s written decision and identify:

1. What exactly did the FDA reject?

Was the problem:

• administrative?
• classification?
• predicate selection?
• intended use?
• technical characteristics?
• test methodology?
• performance?
• clinical evidence?
• labeling?
• risk assessment?
• manufacturing?
• quality systems?

2. Is the problem correctable?

Some deficiencies can be corrected relatively easily.

Others may require:

• new testing;
• redesign;
• additional clinical evidence;
• a different predicate;
• a different intended use;
• or a completely different regulatory pathway.

3. Is the chosen pathway still appropriate?

The manufacturer should reconsider whether:

510(k)

is still the appropriate route, or whether the product should instead be considered for:

De Novo

or

PMA.

23.15 A Regulatory Failure Can Reveal a Product Strategy Problem

Sometimes the FDA decision reveals that the issue is not the submission itself.

The product may have been developed around assumptions that do not match the FDA’s regulatory framework.

For example:

Product development

→ Intended Use

→ Classification assumption

→ Testing strategy

→ Submission

may have been built on an incorrect initial classification.

If that happens, improving the submission document alone will not solve the problem.

The manufacturer may need to go back to an earlier stage of the product development process.

23.16 Why the Pre-Submission Stage Matters

This is one reason why manufacturers should not wait until the final submission to discover whether their regulatory strategy is sound.

Where appropriate, the manufacturer can interact with the FDA before submitting the final application.

Depending on the device and situation, FDA programs such as Q-Submission can provide a mechanism for obtaining FDA feedback on certain planned submissions and regulatory questions.

Early interaction can be particularly useful when there is uncertainty about:

• testing strategy;
• clinical study design;
• regulatory pathway;
• performance requirements;
• substantial equivalence;
• or other important regulatory questions.

The objective is to reduce the risk of discovering fundamental problems only after the formal submission.

23.17 A Practical Example: 510(k) NSE

Consider a manufacturer that submits a 510(k) for a new medical device.

The FDA determines:

Not Substantially Equivalent

The manufacturer should not simply submit the same 510(k) again.

Instead:

FDA NSE

↓

Analyse FDA decision

↓

Identify reason

↓

Is the predicate appropriate?

↓

Are the technological differences adequately addressed?

↓

Is additional testing required?

↓

Is the 510(k) pathway still appropriate?

↓

Choose next regulatory step

This could result in:

New 510(k)

or

De Novo

or, where appropriate,

PMA / reclassification route.

The FDA explicitly identifies these possibilities following an NSE decision.

23.18 What Manufacturers Should Not Do

Several reactions can make an unsuccessful submission more difficult to recover from.

Simply resubmit the same documentation

If the FDA has identified a substantive deficiency, repeating the same evidence is unlikely to solve the underlying issue.

Treat the FDA decision as a testing problem only

Sometimes the problem is not insufficient testing but an incorrect regulatory strategy.

Change the product without regulatory assessment

A product modification can itself create new regulatory questions and may require a new submission.

Ignore the reason for the decision

The FDA’s written decision should be treated as the starting point for the next strategy.

Assume that a different consultant automatically solves the problem

Changing consultants may be useful, but the fundamental issue must first be understood objectively.

23.19 The Goal of a Resubmission

A successful resubmission should not simply be:

“The same application, but with more documents.”

It should demonstrate that the deficiencies identified by the FDA have been specifically addressed.

A useful internal structure is:

FDA concern	Manufacturer response	Supporting evidence
Predicate suitability	Revised predicate rationale	Predicate comparison
Technological difference	Additional evaluation	Test report
Performance concern	Additional testing	Performance data
Safety concern	Risk mitigation	Risk analysis + verification
Clinical question	Additional clinical evidence	Clinical study/report
Labeling issue	Revised labeling	Updated labeling

This creates a direct connection between:

FDA Concern → Corrective Action → Evidence

23.20 The Most Important Lesson

An unsuccessful FDA submission should be treated as a regulatory decision that provides information, not automatically as the end of the project.

The correct next step depends on the reason for the unfavorable outcome.

For a 510(k), the manufacturer may be able to submit a new 510(k), pursue De Novo, seek reclassification or use another appropriate pathway.

For De Novo, additional evidence and a new De Novo request may be possible, or a PMA may become appropriate.

For PMA, the manufacturer may amend, withdraw, request administrative review where applicable, or resubmit after addressing the identified deficiencies.

The key question is therefore not:

“Did the FDA reject our product?”

but:

“Why did the FDA reach this decision, and what regulatory path can address the identified issue?”

That distinction can determine whether an unsuccessful submission becomes the end of a project—or simply the next step toward a successful one.

Conclusion

Bringing a Medical Device to the U.S. Market

Entering the U.S. market with a medical device requires more than identifying the applicable FDA regulation.

A manufacturer needs to understand the complete regulatory pathway — from determining whether the product is a medical device, through classification and the appropriate premarket pathway, to registration, UDI, GUDID and ongoing post-market obligations.

The most important steps can be summarized as:

1. Define the Product
Clearly establish the intended use, indications for use, technology and key product characteristics.

↓

2. Determine Whether FDA Medical Device Requirements Apply
Establish whether the product falls within the FDA definition of a medical device.

↓

3. Determine Classification and Product Code
Identify the applicable FDA regulation, classification and Product Code.

↓

4. Select the Regulatory Pathway
Determine whether the device is exempt from premarket submission or whether a 510(k), De Novo, PMA or another pathway applies.

↓

5. Define the Required Evidence
Determine the testing, performance, clinical and documentation requirements necessary for the selected pathway.

↓

6. Prepare and Submit the FDA Documentation
Compile and submit the required information to the FDA.

↓

7. Prepare for Market Entry
Complete applicable registration, listing, UDI, GUDID and labeling requirements.

↓

8. Maintain Compliance After Market Entry
Manage complaints, reporting, changes, corrective actions, recalls and other applicable post-market requirements.

The most important principle is that regulatory decisions should be made before testing and documentation activities begin.

A clear understanding of the intended use, classification and regulatory pathway helps determine what evidence is actually required.

For manufacturers of products containing wireless technologies or electronic functions, another layer of complexity must be considered: the device may require not only medical-device-specific regulatory assessment, but also extensive RF and EMC evaluation.

This is where the regulatory strategy and the technical test strategy need to work together.

How ScopeRight Can Help

ScopeRight does not replace FDA regulatory consulting, does not submit FDA applications on behalf of manufacturers, and does not determine whether a medical device should be cleared or approved by the FDA.

Its role is different.

For medical devices that contain wireless technologies or electronic functions, ScopeRight can help manufacturers structure and define the RF and EMC compliance requirements that arise from the product.

From Product Characteristics to a Test Plan

Medical devices can contain technologies such as:

• Bluetooth;
• Wi-Fi;
• cellular connectivity;
• RFID;
• NFC;
• proprietary radio technologies;
• wireless charging;
• other RF transmitters and receivers.

At the same time, the device may contain digital electronics, displays, power supplies, motors, sensors and other electronic subsystems that can create EMC concerns.

Determining the appropriate testing can therefore become complex.

ScopeRight helps structure this assessment.

ScopeRight can support manufacturers with:

RF Scoping

Identify the relevant radio technologies, frequency ranges and applicable RF requirements for the product and target market.

EMC Scoping

Determine the relevant EMC test requirements based on the product characteristics, interfaces, technologies and intended markets.

Test Plan Development

Translate the product information into a structured test plan showing which tests are relevant and what needs to be evaluated.

Standards Identification

Identify relevant RF and EMC standards and requirements that should be considered for the product.

Test Time Estimation

Estimate the laboratory effort associated with the defined RF and EMC test scope.

MPE Assessment

Where applicable, ScopeRight can also support RF exposure assessments, including MPE calculations for relevant markets.

Global Market Considerations

For products intended for multiple markets, ScopeRight can help identify differences in RF requirements and approval conditions between markets.

Why This Matters for Medical Devices

For a medical device manufacturer, FDA compliance and RF/EMC compliance are not necessarily separate engineering activities.

A device can have an appropriate FDA regulatory pathway and still require significant additional technical work before it can be placed on the market.

For example, a connected medical device may involve:

Medical Device Requirements
+
RF Requirements
+
EMC Requirements
+
Safety Requirements
+
RF Exposure Requirements

The exact combination depends on the product and the target market.

ScopeRight focuses on helping manufacturers understand and structure these technical compliance requirements before testing begins.

Reduce Uncertainty Before the Laboratory

One of the most expensive points at which to discover an incorrect compliance strategy is after testing has already started.

If the wrong standards, test configurations or test requirements were selected, the manufacturer may face:

• additional testing;
• laboratory retesting;
• project delays;
• unexpected costs;
• documentation gaps.

ScopeRight is designed to move this analysis before the laboratory.

Define the scope. Understand the requirements. Then test.

This approach helps manufacturers enter laboratory testing with a clearer understanding of what needs to be demonstrated.

ScopeRight and FDA Projects

ScopeRight should therefore be viewed as a technical compliance tool that complements the FDA regulatory process, rather than as an FDA submission platform.

The FDA determines the applicable medical-device regulatory pathway and evaluates the corresponding submission.

ScopeRight helps manufacturers with the RF and EMC compliance work that can form an important part of the technical evidence and testing strategy for electronic and wireless medical devices.

In simple terms:

FDA determines whether and how the medical device can be marketed.

ScopeRight helps determine what RF and EMC work needs to be done to prepare the product for testing and market access.

That distinction is important — and it is also where ScopeRight can provide the greatest practical value.

ScopeRight

Control the Scope. Control the Cost.

From product characteristics to a structured RF and EMC test plan, ScopeRight helps manufacturers understand their compliance requirements before testing begins.