Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come
Submitted by kBLASTER Team on
by Chris Henza and Geoff Hutchins for Medical Device and Diagnostic Industry (MDDI)
Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. An excerpt from this commentary stated the following:
Given the release of the “The 510(k) Program” document, it is clear that FDA is standing firmly behind the 510(k) process and is...