What happens when you intend to transfer or sell a 510(k) authorisation to another holder? The new FDA draft guidance seeks to provide clarity.
In the United States, a 510(k) notification is the most common route to obtaining marketing authorisation for a Class II and, in some cases, Class I 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) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), any person required to register their establishment must generally submit a 510(k) notification at least 90 days before beginning to place or proposing to place a device on the market.
But how should one proceed if one intends to transfer an already authorised 510(k) to another party? Need a new notification? What are the responsibilities of the new holder?
These and other questions are answered by the new draft guidance of June 5, 2025, entitled: “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers”.
Structured as a question-and-answer (FAQ) document, the draft is open for public comment until August 4, 2025. 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.
It is important to emphasise that this is not a new regulation, but an interpretative guide (draft Guidance, without binding force) that helps to correctly apply the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and of Title 21 of the Code of Federal Regulations (21 CFR) regarding 510(k) notification, registration (Establishment Registration), listing and UDI.
When you need and when you don’t need a 510(k)
The guide clarifies that it is not necessary to file a new 510(k) notification when:
- the device remains identical in design, components, method of manufacture and intended use;
- there is only a change in who holds the title to the 510(k).
In this case, the new holder must:
- register with the FDA, if not already registered, within 30 days of commencing operations (21 CFR 807.22(a));
- update the Device Registration and Listing Module (DRLM) of the FURLS system, specifying the 510(k) authorisation number already assigned;
- update the GUDID database if information such as the name of the labeller has changed;
- maintain compliance with labelling and Unique Device Identification (UDI) requirements.
A new 510(k) is required when the device being transferred:
- undergoes significant changes in design, components, materials, method of manufacture or intended use;
- is reworked or incorporated into a different system, which may affect its safety or effectiveness.
Some examples of FAQ in the guide
There are five main questions in the FDA document. Below is a selection of significant examples, including some sub-questions or clarifications contained in the main answers.
- Is a new 510(k) required in the case of a change of ownership only, with no changes to the device?
No, as long as the device remains identical and the new holder updates the registration and listing correctly. - Can there be more than one holder for the same 510(k)?
No, according to the FDA, there can only be one official holder for each 510(k) at any given time. - What is the deadline for updating the registration and listing after a transfer?
The new owner must complete registration and update the listing within 30 days of the start of the regulated activity. - How is the update of the GUDID database handled after a transfer?
The new holder, if identified as a labeller, is responsible for entering and updating data in the Global Unique Device Identification Database. - How can one obtain a copy of the original documentation of a 510(k)?
You can request it from the previous holder or submit a FOIA (Freedom of Information Act) request to the FDA.
All FAQs can be found in the document.
Comments open until August 4, 2025
Interested professionals and companies can send comments on the draft directly to the FDA, contributing to the final version of a guide that promises to become an essential industry reference.
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SOURCE:
06/16/2025
