U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. 510(k) Third Party Review Program
  7. Review Memos for Third Party 510(k) Reviewers
  1. 510(k) Third Party Review Program

Review Memos for Third Party 510(k) Reviewers

UPDATE: November 20, 2024

The FDA issued a final guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. This guidance supersedes the previous "510(k) Third Party Review Program" guidance, clarifying how the FDA will use third party review organizations to review 510(k) submissions and may use them to review EUA requests during a future public health emergency.

The FDA posted the following 510(k) review memos to assist Third Party Review Organizations. The FDA cannot share proprietary information, but the FDA is creating a library of redacted memos for selected devices with a high volume of third-party reviews. This commitment is described in Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews (PDF - 223KB).

Review Memo

More Information

Back to Top