On June 5, 2025, the FDA issued draft guidance addressing frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. As transfer of 510(k)s is a common issue during transactions involving medical devices, this guidance, if finalized as written, will provide helpful insight regarding the FDA’s position on the 510(k) requirements in the context of such transactions.
Squire Patton Boggs attorneys Nicole Bothwell, Delia Deschaine, John Wyand, Stephen Chelberg and Jennifer Tharp discuss the FDA’s new guidance in our latest Client Alert, which may be found here.
