The U.S. Food and Drug Administration (FDA) is issuing this draft guidance to provide their current thinking on the use of clinical data in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k) Program.
FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance are consistent with “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance and provide additional clarity and context for situations when clinical data may be necessary to demonstrate substantial equivalence. The recommendations are intended to advance safety and innovation as well as promote consistency and facilitate efficient review of 510(k) submissions that include clinical data.
