FDA developed this document to provide guidance to industry and FDA staff about best practices in selecting a predicate device for premarket notification [510(k)] submissions.
Specifically, this guidance recommends four (4) best practices to employ when selecting a
predicate device used to support a 510(k) submission. The recommendations provided in this guidance are not intended to propose any changes to applicable statutory and regulatory standards, such as how FDA evaluates substantial equivalence, or the applicable requirements, including the requirement for valid scientific evidence. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process. This guidance and associated recommendations are consistent with and are intended to be used in conjunction with the FDA guidance “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (hereinafter, 510(k) Program Guidance) and other relevant FDA guidances on 510(k) submissions…
