Medical Device Legal News with Sam Bernstein: Episode 11
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more