On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance discusses the FDA’s recommendations on handling the purchase, sale, or other transfer of a medical-device 510(k) clearance, and requests public comments. Stakeholder comments are due by August 4, 2025. Stakeholders submitting comments should consider the 510(k) Transfer Guidance from both a regulatory and transactional perspective.

The 510(k) Transfer Guidance reiterates that, under section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), and 21 C.F.R. Part 807, a person who introduces a non-exempt device into U.S. commercial distribution for the first time must obtain a 510(k) clearance; once obtained, that person becomes the singular “510(k) holder” for the device. Because only one entity can be the 510(k) holder at any given time, the transfer or sale of clearance does not create multiple holders; instead, it shifts holder status to the transferee. 

The 510(k) Transfer Guidance clarifies that a transferee generally does not need to submit a new 510(k) if the underlying device has not undergone significant changes or modifications in design, components, manufacturing method, or intended use.  Instead, the new holder must satisfy certain post-transfer administrative obligations, including updating the registration and listing information in the FDA establishment registration database.  In the transaction context, companies should consider whether any manufacturing, supplier or other technical changes as part of the transaction warrant submission of a new 510(k), and whether these processes, or associated timing considerations, merit submitting comments for consideration by FDA. 

Importantly, the 510(k) Transfer Guidance also emphasizes the importance of updating the Global Unique Device Identification Database (GUDID) when information such as the labeler's name changes. These types of updates are similarly important in the transaction context, as labeling changes can take time and require planning. Failure to properly register, list, or update required GUDID information may render a device adulterated or misbranded. 

Finally, the 510(k) Transfer Guidance distinguishes the responsibilities of various entities in the device supply chain, specifying which entities can use a 510(k) holder’s 510(k) number to list a device. Contract manufacturers, contract sterilizers, repackagers, and relabelers must use the cleared 510(k) number when listing, whereas initial importers may satisfy listing obligations by identifying the foreign manufacturer if they neither relabel nor repackage the device. The 510(k) Transfer Guidance emphasizes that, generally, the specification developer, not the contract manufacturer, is responsible for submitting the 510(k).