FDA issues draft document on when a 510(k) is needed

The FDA has released draft guidelines ("510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device") that outline the types of changes to previously cleared 510(k) devices that will require device makers to submit new premarket applications. Such changes could include new labeling, technology or performance parameters.

The draft guidance is now open to public comment. It will supersede the 1997 version of this guidance. The new guidance is one of the fruits of the agency's ongoing exhaustive review of the 510(k) system. That process will reach another milestone when the Institute of Medicine, part of the National Academies of Science, releases its long awaited report ont he 510(K) process.