Submitted by kBLASTER Team on
A recent FDA webinar distributed slides and an audio recording with transcript, which was intended to clarify recently released guidance titled The 510(k) Program Guidance: Evaluating Substantial Equivalence in Premarket Notifications. As described in a previous posting, issues regarding primary predicates and split predicates were discussed heavily.
Both the recorded transcript and slides presented in webinar by Marjorie Shulman stated that "A reference device is a legally marketed device intended to provide scientific information to support safety and effectiveness. A Reference device is not a predicate and cannot be used to support decision points one through four on the flowchart".
The webinar can be accessed at How to Market Your Device Updated 8-15-14 at The 510(k) Program Guidance: Evaluating Substantial Equivalence in Premarket Notifications selection dated August 15, 2014.