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)