FDA Moves to Modernize Medical Devices Premarket Program (1)

The Food and Drug Administration released a trio of guidances Wednesday aimed at modernizing a process regulating medical devices.

The agency published three draft guidances to improve the predictability, consistency, and transparency of the Premarket Notification 510(k) Program, which allows manufacturers to say that their devices can be marketed through FDA regulation.

The draft guidances recommend practices for selecting a predicate device for the program, situations when clinical data may be necessary in a 510(k) submission, and evidentiary expectations for 510(k) submissions for implanted devices, according to the FDA.

“In light of this increasing technological complexity, clinical data are increasingly ...