FDA registration of medical devices

Market Access USA

Many of you will have heard that a FDA registration is necessary to legally sell medical devices in the USA. These procedures include, for example, a Premarket Notification 510(k) or a Premarket Approval (PMA). There is also another, less known procedure. The so-called De Novo Program of the FDA. But device registration “alone” is not enough. Besides that, there are other requirements that must be met: Your quality management system must meet the requirements of the Quality System Regulation (QSR), and devices and companies must be registered with the Food and Drug Administration. In this blog, we explain the steps necessary on the path to US registration of your devices.

We have years of experience in launching medical devices in the USA. If you have any questions or need support, we look forward to hearing from you.

The Food and Drug Administration (FDA)

The FDA is a U.S.-based agency. It reports to the Department of Health and Human Services and is responsible for overseeing food, drugs, and medical devices. As is typical for such an agency, its core task is to protect citizens. To fulfill this task, certain devices cannot be sold in the USA without registration. They need FDA registration.

Unlike authorities in Germany, the FDA has some influence on the requirements to be met as part of the registration process. It has the authority to enact certain laws that must then be observed during the registration process. These laws are included in Section 21 of the Code of Federal Regulations (CFR).

The FDA is considered a very strict authority worldwide. This leads to most companies being downright afraid of an FDA audit. Of course, the FDA has the option to order an import ban or similar unpleasant measures. However, a sales stop can also happen to you in the EU if requirements are not met. The key to a good night’s sleep in both the EU and the USA is therefore good preparation and implementation of regulatory requirements.

There are guidelines for many topics relevant to FDA registration. These provide the agency’s expectations and actually help you to position yourself well in regulatory terms.

Deviations

Deviations in the FDA registration process can occur during the registration procedure (pre-market) or during an existing registration (post-market).

During the registration process, the FDA will inform you of the respective deviations, and these must be rectified by you within the specified deadline. The deadlines are specified in the respective procedures. Since the FDA’s reviews are very detailed, deviations in registrations are common. The important thing is that the deviations are not so serious that they become a problem in the project. However, you largely rule this out through good preparation and expertise in technical and regulatory aspects. In our projects so far, there have been no deviations so serious that an registration has failed. The deviations occurring during FDA registration are not published.

Deviations can also occur if you already have a registration for the US market and the FDA identifies deviations, for example, during an inspection of your company.

Deviation during the registration process

As mentioned, deviations regularly occur during FDA registration procedures. The most common procedure is the Premarket Notification 510(k). Therefore, we use this procedure as a current example.

A 510(k) is roughly divided into 6 steps by the FDA:

Day 1: Receipt of the 510(k) by the FDA
Up to Day 15: The FDA conducts a so-called “Acceptance Review”.
Up to Day 60: The FDA conducts a so-called “Substantive Review”.
Up to Day 90: The FDA communicates the final decision.
Up to Day 100: If the final decision has not been made by Day 100, the FDA communicates open points from the review.

Acceptance Review

If deviations are identified during the Acceptance Review, this leads to an RTA Hold. The manufacturer then has 180 calendar days to address the open deviations. If this does not happen, the FDA considers the 510(k) withdrawn and deletes it. To still achieve registration, a new 510(k) must then be submitted. The process starts completely from the beginning.

Substantive Review

Within 60 days of receiving the 510(k), the FDA conducts a comprehensive review. The communication between FDA and manufacturer taking place in this context can either be an “Interactive Review” or an “AI Request” is issued. With the Interactive Review, there is no delay; with the AI Request, the registration is paused until the open points are clarified.

The AI Request must also be completed within 180 calendar days. The countdown begins when the FDA issues the AI Request. If this does not happen, the 510(k) is again considered withdrawn.

It’s important to note that the clock runs on both sides of the registration based on formal requirements. The clock runs against the FDA as long as the registration is not “on hold”, i.e., during the RTA Hold or AI request.

The clock runs against the manufacturer, on the other hand, when the registration is “on hold”, because the manufacturer must then close the open questions or deviations within the deadline.

Deviation During Inspections

Deviations can lead to different formal measures on the FDA’s side.

The following measures are sorted by criticality.

Level 1: FDA Form 483 (Deviation report by the FDA)
Level 2: Warning letter
Level 3: Sales stop / Recall

For example: If a deviation is identified via Form 483 and the company does not respond adequately, a Warning Letter is published. If there is again no adequate response, the FDA can, for instance, impose a sales stop. During the process, the manufacturer has the opportunity to discuss the procedure with FDA representatives and discuss measures. A sales stop usually doesn’t occur unexpectedly.

Due to publication, deviations can lead to image damage for companies. You can view a list of published Warning Letters at the FDA.

The right registration procedure

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Classification of the Product

Determining the “Product Code”

You can find Product Codes using the FDA’s 510(k) Premarket Notification Database or the Premarket Approval (PMA) Database. For example, enter a product from another manufacturer that is similar to your product in the Device Name field of the 510(k) database. In this example, we are using the approximate name of an endoscope from a well-known manufacturer. We have not obtained permission to use the product name and related information. For this reason, the corresponding fields in the graphics are deleted.

After you have entered the approximate Device Name, you will be shown a list of search results. Choose the most appropriate result. You will then be shown the following view, from which you can extract the desired Product Code.

As you can see, this endoscope is even assigned multiple Product Codes. This is related to the intended use and means that you must comply with the requirements for each individual Product Code.

You can now open the codes and the Regulation Number. For the code NWB, for example, you will see the following:

This overview shows you that you need to use a 510(k) as the type of registration. The “recognized consensus standards” are standards that you should comply with for products of this code. From the “Regulation Number”, you can derive the legal basis from the Code of Federal Regulations (21 CFR).

In this way, you can determine step by step the requirements for each individual Product Code that is applicable to your product. In the “ideal case”, of course, it’s only one, which makes your life easiest. But as you can see, there are products where the intended use and range of functions lead to multiple codes.

Types of registration according to product code

For Class III products, a Premarket Approval (PMA) is usually required
If you were able to determine a Product Code, a Predicate Device is available, and the Product Codes require a 510(k), you can take the route of a Premarket Notification to get your product approved. The comparison with the Predicate Device is the basis for argumentation in the registration. All differences are discussed and assessed for their impact on safety and performance.
Couldn’t determine a suitable Product Code for your product? This means your product type hasn’t been approved by the FDA yet. New products like this are initially classified as Class III by the FDA. If you want your product to be classified as Class I or II, the FDA’s De Novo Program is the right approach.
Your product doesn’t require registration through PMA or PMN? In this case, you still need to list the product with the FDA.

“Registration and Listing”

Companies involved in the manufacturing and distribution of medical devices for use in the United States must register annually with the FDA. This process is known as “establishment registration”. In 2020, the cost for this was $5,236.

Most companies required to register with the FDA must also list their products for the US market. If a product needs Premarket Approval or Premarket Notification before being marketed in the USA, the identification number of the registration must be provided. Registration and listing are done electronically.

U.S. Agent

If your company is considered a “foreign establishment” and is involved in the manufacturing, preparation, distribution, assembly, or processing of a product imported into the USA, you need a U.S. Agent.

The U.S. Agent must either reside in the USA or maintain an establishment there. Their responsibilities relate to

assisting the FDA in communicating with your company
answering questions regarding your products that you want to market in the USA
assisting the FDA in planning inspections of your company
If the FDA is unable to contact your company directly or quickly, the FDA may provide information or documents to the U.S. Agent, and such action will be considered equivalent to providing the same information or documents to your company.

As part of your “facility registration”, you provide the name of the U.S. Agent. This is done electronically through the FDA Unified Registration and Listing System (FURLS system).