Summary: The FDA issued updated guidance on the 510(k) Third Party Review Program and Third Party EUA Review, clarifying expectations, processes, and criteria for third party review organizations involved in device and EUA evaluations.

Key Takeaways:

  • The guidance refines standards for third party review organizations, addressing eligibility, review procedures, and conflict of interest requirements.
  • It supersedes the 2020 guidance and integrates international standards to enhance the 3P510k Review Program’s scope and functionality.

The U.S. Food and Drug Administration (FDA) announced the availability of the “510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review” guidance.

This guidance updates the previous “510(k) Third Party Review Program” guidance, providing further clarity on the 3P510k Review Program and explaining how FDA may utilize third party review organizations for initial reviews of Emergency Use Authorization (EUA) requests for all devices, including in vitro diagnostics.

FDA Expectations and Criteria

The guidance:

  • Differentiates FDA’s expectations for 3P510k Review Program and 3PEUA review.
  • Describes criteria for determining device type eligibility for 3P510k review.
  • Outlines FDA’s expectations for third party review organizations conducting substantial reviews of 510(k) submissions and EUA requests.
  • Provides details on the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k Review Organizations.
  • Clarifies expectations regarding compensation for third party review organizations.

The guidance also discusses how FDA plans to incorporate the International Medical Device Regulators Forum’s (IMDRF) documents into the 3P510k Review Program.

Superseding Prior Guidance

This guidance replaces the “510(k) Third Party Review Program; Guidance for Industry, FDA Staff, and Third Party Review Organizations” issued on March 12, 2020.

FDA considered public comments and updated the guidance to:

  • Clarify the relationship between 510k Review Organizations and EUA Third Party Review Organizations.
  • Address conflicts of interest for personnel within Third Party Review Organizations.

Non-Binding Nature

The guidance reflects FDA’s current thinking but does not establish binding requirements for FDA or the public. Alternative approaches may be used if they meet applicable statutory and regulatory requirements.