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

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 This revised draft supercedes the draft guidance published on August 13, 2012.