Skip to main content
U.S. flag

An official website of the United States government

Return to Search

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

Final

Issued by: Food and Drug Administration (FDA)

Issue Date: March 12, 2020

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.