FDA registrations for medical devices

Many of you will have heard that FDA registration is required to legally market medical devices in the USA. These procedures are for example a Premarket Notification 510 (k) or a Premarket Approval (PMA). There is also another, less well-known procedure. The so-called De Novo Program of the FDA. But "only" a product registration is not enough. There are other requirements besides the approvals that have to be fulfilled: Your quality management system must meet the requirements of the Quality System Regulation (QSR), products must be listed and establishments registered with the Food and Drug Administration. In this blog we will explain to you which steps are necessary on the way to US approval.

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

21 CFR Part 820 – QSR

What?! What sounds a little cryptic here is the reference to the FDA's Quality System Regulation. This describes the most important requirements for a quality management system with which you may market products in the USA. It also describes which records the FDA expects from you - so it is interesting to have a look at these requirements long before a US approval. In 21 CFR 820 you will also find information about design controls. At this point, it is recommended that you compare the requirements of the QSR with your existing development process.

It may sound simple, but a manufacturer must implement and maintain procedures for defining and documenting design output in a manner that allows for proper assessment of conformity with the requirements for design input. We have often found that customers have not been entirely clear about what the design output of their development process actually is. The verification process then sometimes examined aspects that did not sufficiently demonstrate that the requirements of the design input were implemented in the design output.

With regard to the requirements of the Quality System Regulation, you are already well positioned with an existing QMS according to ISO 13485. But there are many details that need to be considered. We advise you to use a gap analysis to find out which requirements you have not yet or not sufficiently implemented. So, before you obtain US approval, make sure that your company is well prepared at the QMS level.

„Registration and Listing“

Companies involved in the manufacture and distribution of medical devices for use in the United States must register with the FDA annually. This process is called "establishment registration". In 2020, the cost of this process amounted to USD 5,236.

Most companies that must register with the FDA must also list their products for the US market. If a product requires Premarket Approval or Premarket Notification before it can be marketed in the USA, the identification number of the approval must be included. The registration and the listing are carried out electronically.

U.S. Agent

If your company is considered a "foreign establishment" and is involved in the manufacture, preparation, distribution, assembly or processing of a product imported into the U.S., you will need a U.S. agent.

The U.S. agent must either reside in the U.S. or have a branch office there. His or her responsibilities relate to

Supporting the FDA in communicating with your company

• Answering questions about your products that you want to market in the USA.
• Support of the FDA in planning inspections in 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 will identify the U.S. Agent by name. This is done electronically through the FDA Unified Registration and Listing System (FURLS system).

Identification of an appropriate registration procedure

We have already described that you have to list your products and register your company. However, in order to list products, you must first approve them - if necessary. If this is not necessary, you do not need a unique registration number for the product, which you will receive when you successfully pass an approval process. You can therefore list the products without FDA registration

But let us assume that your product has to be registered. How do you know whether to use a Premarket Notification 510(k), a Premarket Approval or the FDA's De Novo Program?

Do you know the risk class of your product? This is an important first step in choosing one of the approval procedures. Do you know the product code that regulates the appropriate product type at the FDA? This is ideal! Because this is how you can find out which requirements you have to comply with.

Determination of a product code

Product codes can be found using the 510(k) Premarket Notification Database or the FDA's Premarket Approval (PMA) Database. For example, in the Device Name field of the 510(k) database, enter a product from another manufacturer that is similar to your product. In this example we use the approximate name of an endoscope from a known manufacturer. We have not tried to obtain permission to use the product name and related information. For this reason, the corresponding fields in the graphics have been deleted.

After you have entered the approximate Device Name, a list of search results is displayed. Select the most appropriate result. You will then be presented with the view below, from which you can extract the product code you are looking for.

As you can see, this endoscope is even assigned several product codes. This is related to the intended purpose and means that you must comply with the requirements for each product code.

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

In this overview you will see that you must use a 510 k as the type of approval. The recognized consensus standards are standards that you should comply with for products of this code. The Regulation Number gives you 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 applies to your product. In the "ideal case" it is of course only one, which makes life easier for you. But as you can see, there are products where the intended purpose and scope of functions mean that there are several codes.

Approval types according to product code

• For Class III products, a Premarket Approval (PMA) is usually required
• If you have been able to determine a product code, a predicate device is available and the product codes require a 510(k), you can go through a premarket notification to get your product approved. The comparison with the Predicate Device is the basis of the argumentation in the approval process. All differences are discussed and assessed for their impact on safety and performance.
• You could not find a suitable Product Code for your product? Your product type has therefore not yet been approved by the FDA. New products like this one are initially classified by the FDA as Class III. If you want to have your product classified in Class I or II, the FDA's De Novo Program is the right method.
• Your product does not require approval? In this case, you must still list the product with the FDA.

Are you unsure of the classification?

The Food and Drug Administration offers the possibility to submit a request for classification. This way is called 513(g) and refers to the reference within the Food, Drug & Cosmetic Act.

It describes that the FDA must provide a requestor with information regarding the risk class of a product within 60 days.

If you are not sure about the classification of your medical device, do not start the approval process yet. Clarify the uncertainties in advance to make the right choice and avoid unnecessary delays in the project.

Summary

Even before product approval in the USA, there are many things to consider. Your quality management system must meet the requirements of Quality System Regulation 21 CFR Part 820 and, if applicable, other regulatory requirements. You must register your company with the FDA and appoint a U.S. agent. Then, taking into account the risk class and product code, you must identify the correct approval procedure and the requirements, standards and guidance applicable to the product. Only then does the product approval via a Premarket Notification 510(k), Premarket Approval or as De Novo begin.