MD marketing in the USA: what are the steps of the 510(k) submission procedure?

Why market a medical device in the United States?

The USA is currently the largest medical device market, accounting for 45% of the global market. It therefore offers non-negligible prospects for growth, as well as the advantage of having clear marketing procedures centralised by the FDA.

There are currently several approval pathways:

• PMA: for Class III devices
• De novo: for innovative devices
• 510(k): for Class I and II devices, and for some Class III devices
• HDE, for devices that are intended to benefit patients with rare diseases (<8,000 cases/year in the USA)

What is the FDA?

The FDA is the US Food and Drug Administration. One of its main tasks is to authorise the marketing of medicinal products in the United States. It is responsible for protecting public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices.

Why and how should one submit a 510(k)?

The submission of a 510(k) is the most common process for accessing the US market; it is based on the demonstration of equivalence. This approval process has the advantage of being clearly defined (numerous guides published by the FDA give clear instructions) with fixed submission costs and a maximum 90-day period for review by the FDA.

Equivalence is demonstrated based on a comparison with one or more similar medical devices, referred to as “predicates”, that are already available on the market.The predicate device must have the same intended use and the same technical characteristics (or at least these must not raise questions about the safety or efficacy of the medical device).

Preparing a 510(k) is part of a six-step process to obtain US marketing authorisation for a medical device under 21 CFR. This regulation consists of 21 sections necessary to demonstrate that the product to be marketed is safe and effective. For example, there are sections associated with biocompatibility and sterilisation test results, administrative information, the payment of fees, etc.

Equivalence is demonstrated based on:

• Special controls, i.e. the regulatory requirements applying to a particular type of MD (21 CFR Parts 862-892)
• Performance and safety tests
• Clinical data (included in only 10% of 510(k)s)

There are three types of 510(k)s:

• Traditional: used for new MDs; substantial equivalence (SE) is demonstrated based on performance and safety tests
• Special: used for changes to an MD; the predicate is made by the same manufacturer
• Abbreviated: the manufacturer demonstrates SE based on FDA guidance documents, by demonstrating compliance with special controls and international standards

Where can the FDA guidance documents be found?

The FDA guidance documents can be retrieved from the classification database or through the FDA’s research databases on Guidance & Standards.

How can predicates be identified?

To identify predicates that can be used to determine substantial equivalence, the FDA’s database should be used. The first step is to identify the product code, which is available in the “Product classification” tab that sets out all of a product’s classification data. The product code should be entered in the database to obtain lists of all the devices that have the same product code and are therefore similar to the product for which a submission dossier is being prepared. These devices may be chosen as predicates.

What is the time frame for obtaining a marketing authorisation?

Between 18 and 24 months are necessary from the project’s launch to the product’s marketing on American soil, based on a QMS compliant with 21 CFR Part 820 and a complete Design History File (DHF).

Why should you turn to Efor for assistance?

Our teams include a number of consultants with expertise relating to medical devices. They are able to provide you with specific, in-depth support to meet your needs.

Our quality and regulatory affairs experts will be pleased to offer you high-quality support with regard to all of the following topics (non-exhaustive list):

• Support in defining a regulatory strategy, with definition of the class of device and the applicable guides, standards and regulations.
• 510(k) writing support
• Support in establishing and ensuring compliance with the US requirements specific to the QMS and product according to 21 CFR Part 820
• DHF updating support
• Support for administrative registration with the FDA
• Auditing

To be supported in your steps to access the American market, feel free to contact us by using our contact form.