{"id":34283,"date":"2025-06-16T14:09:24","date_gmt":"2025-06-16T12:09:24","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34283"},"modified":"2025-06-23T15:30:19","modified_gmt":"2025-06-23T13:30:19","slug":"510k-divestment-in-the-u-s-open-comments-for-new-draft-guidelines","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/06\/16\/510k-divestment-in-the-u-s-open-comments-for-new-draft-guidelines\/","title":{"rendered":"510(k) Transfer in the U.S.: Public Comments Open on the New Draft Guidance"},"content":{"rendered":"

What happens when you intend to transfer or sell a 510(k) authorisation<\/strong> to another holder? The new FDA draft guidance seeks to provide clarity.<\/p>\n

In the United States, a 510(k) notification<\/strong> is the most common route to obtaining marketing authorisation for a Class II <\/strong>and, in some cases, Class I<\/strong> medical device. Through this procedure, the manufacturer demonstrates that its device is substantially equivalent to another device already legally on the market (predicate device). Under Section 510(k)<\/strong> of the Federal Food, Drug, and Cosmetic Act (FD&C Act)<\/strong>, any person required to register their establishment must generally submit a 510(k) notification at least 90 days <\/strong>before beginning to place or proposing to place a device on the market.<\/p>\n

But how should one proceed if one intends to transfer an already authorised 510(k) to another party<\/strong>? Need a new notification? What are the responsibilities of the new holder?<\/p>\n

These and other questions are answered by the new draft guidance of June 5, 2025<\/strong>, entitled: \u201cTransfer of a Premarket Notification (510(k)) Clearance \u2013 Questions and Answers\u201d<\/strong><\/a>.<\/strong><\/p>\n

Structured as a question-and-answer (FAQ)<\/strong> document, the draft is open for public comment<\/strong> until August 4, 2025<\/strong>. The objective is to clarify the critical points related to the transfer of ownership of a 510(k), a very common situation in the context of company acquisitions, mergers or reorganisations<\/strong>.<\/p>\n

It is important to emphasise that this is not a new regulation, but an interpretative guide (draft Guidance, without binding force) that helps to correctly apply the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act)<\/strong><\/a> and of Title 21 of the Code of Federal Regulations (21 CFR)<\/strong><\/a> regarding 510(k) notification, registration (Establishment Registration), listing and UDI.<\/p>\n

When you need and when you don’t need a 510(k)<\/strong><\/h3>\n

The guide clarifies that it is not necessary to file a new 510(k) notification<\/strong> when:<\/p>\n