510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

This guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the review of 510(k) submissions and EUA requests by third party review organizations.

This guidance provides updated recommendations on the 510(k) Third Party Review Program and supersedes the “510(k) Third Party Review Program” guidance.