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In this section: 510(k) Third Party Review Program

Review Memos for Third Party 510(k) Reviewers

The FDA posted a redacted surgical mask 510(k) review memo 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

Surgical mask 510(k) review memo (redacted PDF)

More Information

Training, Guidance, and Other Resources for Third Party Review Organizations

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