August 2012

Proposed 510(k) guidance from FDA requires agency response to applicant in 15 days

Submitted by kBLASTER Team on

by Arundhati Parmar for Med City News

Commentary on regulatory implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s.  This proposed guidance to expedite the acceptance process for the 510(k) program at the FDA would require the agency to respond in 15 days to an applicant and signals a marked shift to almost 20 year old guidance regarding 510(k) acceptance policy...

Draft Guidance – Refuse to Accept Policy for 510(k)s

Submitted by kBLASTER Team on

This FDA guidance document published on August 13, 2012, is being distributed for comment purposes only and contains nonbinding recommendations regarding an FDA checklist for refusal to accept 510(k)s. This guidance document includes nine instances of predicate requirements within this checklist for 510(k)s, along with numerous other items on the checklist....

Review of FDA's Highly-Anticipated Draft Guidance on the 510(k) Program

Submitted by kBLASTER Team on

Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] by Jonathan S. Kahan, Jennifer Agraz Henderson, Kelliann H. Payne for Update Magazine , The Food and Drug Law Institute, July/August 2012

Excerpts from this commentary highlights that the FDA guidance focused on...