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 reviews of 510(k) submissions and EUA requests by third party review organizations.
This draft guidance provides updated recommendations on the 510(k) Third party Review Program previously discussed in the 2020 final guidance, “510(k) Third Party Review Program.” The 2020 final guidance remains in effect until this draft guidance is finalized.
FDA may contract with third party review organizations to perform reviews of Emergency Use Authorization (EUA) requests (3PEUA review) when appropriate emergency declaration authorities are active under section 564 of the FD&C Act. FDA has previously contracted with third party review organizations to perform reviews for 3PEUA review when appropriate emergency declaration authorities are active under section 564 of the FD&C Act
What Is a Third-Party Review?
A third-party review refers to an evaluation of a product, service, or individual conducted by someone who is not directly affiliated with the concerned entity. This provides an unbiased perspective, serving as a reliable source of information for potential customers and clients.
Takeaway: When final, this guidance will supersede “510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations” issued on March 12, 2020.
