Transfer of a Premarket Notification (510(k)) Clearance Guidance

Submit Comments by 08/04/2025

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s docket number: FDA-2024-D-1528

Docket Number: FDA-2024-D-1528 Issued by:

Guidance Issuing Office

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

This guidance provides information on frequently asked questions regarding the transfer or sale of a premarket notification (510(k)) clearance from one 510(k) holder to another. Under the Federal Food, Drug, and Cosmetic Act and its implementing regulations, any person who is required to register their establishment must generally submit a premarket notification if a device is subject to the requirements of section 510(k) and the person is either introducing the device into commercial distribution for the first time, or the device is already in commercial distribution, but the person is about to significantly change or modify its design, components, method of manufacture, or intended use.