Home » FDA Releases Long-Awaited Device Changes Guidance, Industry Reacts
FDA Releases Long-Awaited Device Changes Guidance, Industry Reacts
The device industry immediately reacted negatively to the FDA’s release of a draft guidance on 510(k) device modification, saying the requirements could result in an exodus of devicemakers from the U.S.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
Upcoming Events
-
07May
-
14May
-
30May