U.S. flag An official website of the United States government
  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: August 19, 2022: If manufacturers are considering seeking 510(k) clearance for personal protective equipment, most masks (such as product code FXX) and gloves (such as product codes LYY, LYZ, LZA, KGO, and LZC) are eligible for 510(k) Third Party Review.

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