510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

Issue Date: November 21, 2024
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Administrative / Procedural
Status: Final

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

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.

Download the Guidance Document