Submitted by kBLASTER Team on
This final FDA guidance document published on December 31, 2012 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. This revised draft supercedes the draft guidance published on August 13, 2012....
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in December 2012, as well as FDA splash pages from 510(k)s cleared in December 2012 and January 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the January 13th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.
With more than 55,000 510(k) summaries to choose from, including more than 73,000 splash pages, find your best single primary predicate fast, saving you time and money on the...
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The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (draft guidance issued 12/27/11)
Refuse to Accept (RTA) Policy for 510(k) Submissions (first draft guidance issued 8/13/12, latest draft guidance issued...