Submitted by kBLASTER Team on
CDRH at FDA has indicated as part of MDUFA III that numerous “A-list” draft FDA guidance documents that are pertinent to the predicate selection process are intended to be released as final guidance in 2013, including:
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (draft guidance issued 12/27/11)
Refuse to Accept (RTA) Policy for 510(k) Submissions (first draft guidance issued 8/13/12, latest draft guidance issued on 12/31/12)
The Pre-Submission Program and Meetings with FDA Staff (draft guidance issued 7/13/12)