FInal Guidance for Industry and FDA Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

PDF link to Final guidance was published by FDA on July 28, 2014 titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. This guidance suggested calling out a single primary predicate in all 510(k) submissions.  Furthermore, this guidance has stated the use of "split predicates as inconsistent with the 510(k) regulatory standard". Guidance states that multiple predicates are still allowed, but each predicate included must have identical intended use. Additional information is available at a previous posting.