510(k) Third-Party Review Program

This ICR collects information from persons who wish to be accredited by the Agency to review certain premarket notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's premarket notification for selected medical devices. After reviewing a submission, the reviewer will forward a copy of the submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers also maintain records of their reviews and a copy of the submission. The purpose of the program is: (1) to provide manufacturers of eligible devices with an alternative review process that could yield more rapid marketing clearance decisions and (2) enable FDA to target its scientific review resources at higher-risk devices while maintaining confidence in the review by third parties of low-to-moderate risk devices.

The latest form for 510(k) Third-Party Review Program expires 2022-11-30 and can be found here.