January 2012

New FDA Draft Guidance on 510(k) program

Submitted by kBLASTER Team on

by Vesa Janic on January 26, 2012

Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].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 highlights that the FDA guidance focused on major points which include:

  • The FDA will continue to allow the use of multiple predicates in certain circumstances to help demonstrate SE,
    • ...

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Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].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...