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 The 510(k) Program Guidance: Evaluating Substantial Equivalence in Premarket Notifications. This discussion included questions and answers from interested parties regarding a number of topics, including the specification of a single primary predicate in a 510(k) submission. This webinar was led by Marjorie Shulman [Director, Premarket Notification Program, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) at FDA], with additional comments from Dr. Joni Foy (Deputy Director for Engineering and Science Review for the ODE, CDRH at FDA). 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 8-15-14.
The slides presented in webinar by Marjorie Shulman stated that the primary predicate is “the identified predicate with indications and technology most similar to the subject device when multiple predicates are identified” and selection of a primary predicate “can facilitate a timely review and well-supported decision”.
A transcript of the discussion by Marjorie Shulman stated the following regarding primary predicates and split predicates:
--“And everyone’s favorite term split predicate which is using one legally marketed device for intended use and a different legally marketed device for technological characteristics to demonstrate substantial equivalent. The use of split predicates is inconsistent with the 510(k) regulatory standard.”
--“You do need a primary predicate to get you through all the way through the flowchart” that establishes substantial equivalence
--“The purpose of the primary predicate is the device with the indications and for use and the technological characteristics that are most similar to the new device. So it should be identified within the 510(k) submission. The multiple predicates are certainly allowed also but you need one primary predicate to get you all the way through the flowchart.”
--"If using multiple predicate devices to demonstrate substantial equivalence each predicate device must have the same intended use as the new device and any different technological characteristics between the new device and the predicate must not raise different questions of safety and effectiveness."
--“You have one primary predicate that has the overall intended use of the device that you’re looking to market.”
--“And anything that’s currently under review we’re not going to contact the companies and go back and ask for which was the primary predicate and which were the reference devices. It’s just for any ones in the future and if you have one that you’ve already prepared and it’s ready to be sent here we don’t expect to redo it at this time either. So it’s not going to be a refuse to accept item.”
A transcript of the discussion by Dr. Joni Foy stated the following regarding primary predicates:
“And so the distinction that we’re trying to make with identification of a primary predicate is to pick the one predicate that you think is most similar to your product. It’s not a requirement that you have to only identify one but it helps to streamline the review process because we look and your characterization in comparison is done to that particular product. So that’s the impetus for a primary predicate is to try to streamline both the testing that you do on your end as well as the review process on the agency side.”