Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 7, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Draft

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

FDA is issuing this draft guidance to provide our current thinking on the use of clinical data in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k)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 FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance are consistent with “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance, and provide additional clarity and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.

Download the Guidance Document