Whose 510(k) Is It Anyway?

FDA recently released a draft guidance regarding the transfer or sale of a 510(k) clearance. When a 510(k) for a device is sold or transferred from one entity to another, the new 510(k) holder must list the device with the FDA.  If the device has not been significantly changed or modified, the new 510(k) holder is required to provide the original 510(k) number when creating their device listing.

FDA notes that the sale or transfer of a 510(k) may involve changes to labeling, such as the name of the place of business and/or the device brand and model name, which likely requires a new unique device identifier (UDI) and as such will also require an update submission to FDA’s Global Unique Device Identification Database (GUDID).  Failure to register, list, or update GUDID information may render the device either adulterated, misbranded, or both. FDA has received requests from new 510(k) holders requesting that FDA update the information (e.g., establishment registration and device listings); however, this is the responsibility of the new 510(k) holder.  While it is true the new 510(k) holder can electronically update the device listing and establishment registration, unfortunately, the 510(k) database does not get updated.  This is unfortunate given that Sponsors typically search the database by applicant name or device name when searching for potential predicate devices. It would be an improvement if there was a way to update the 510(k) database with the new 510(k) holder name and new device name, or at least a way to search the registration and listing database by the 510(k) number.

While FDA’s guidance does not address considerations beyond transfer of a 510(k), there are other items that the purchaser should be aware of when acquiring a 510(k).  For example, the purchaser should ensure that, as part of the transaction, they receive a complete copy of the 510(k), including all correspondence to and from FDA regarding the submission.  If the purchaser fails to do so, the only other way to obtain the 510(k) would be through a Freedom of Information Act (FOIA) request, which can take a significant amount of time (especially at the current FDA, which has been hit hard with cuts to FOIA staff).  In addition, Sponsors should also obtain copies of all prior “Letters to File” documenting the prior 510(k) holder’s analysis of changes implemented since receiving clearance of the 510(k) being transferred or sold.

Finally, because FDA believes there can only be one 510(k) holder for a device at a time, the 510(k) purchaser should ensure there are appropriate representation and warranties in the acquisition documents establishing that the purchaser is the sole owner/holder of the 510(k).

Interested parties can submit comments regarding the draft guidance until August 4, 2025.