On January 26, 2018, FDA issued the first performance metrics for third-party reviewers of 510(k). Going forward, a summary of Third Party Performance Metrics will be posted on a quarterly basis. At this time, there is one Third Party Review Organization with at least 5 completed submissions. A Third Party 510(k) submission goes through four different stages before a final decision is made by FDA. In stage A, the Third Party receives the file from the 510(k) Submitter, reviews the file, and sends the file and its decision recommendation to FDA. In stage B, FDA reviews the submission to ensure that the Third Party has submitted all the information needed to make a final decision. If more information is needed, FDA makes a request of additional information, notifies the Third Party, and puts the submission on hold. In stage C (Optional), The Third Party reviews FDA’s request for additional information and notifies the 510(k) submitter. The Third Party responds to FDA’s deficiencies, updating the review memo and submission as necessary. The submission is considered on hold until FDA receives a complete response to its request for additional information. In stage D, FDA reviews the additional information and makes a final decision.
The 510(k) Third Party Review Program provides medical device manufacturers with an alternative review process, in which accredited Third Party Review Organizations (Review Organizations) are allowed to review certain low-to-moderate risk medical devices. The program is intended to help yield more rapid 510(k) decisions and to allow the FDA to focus its resources on higher risk devices, while still maintaining oversight of the review of lower risk devices eligible for third party review. This program is formally known as the Accredited Persons Program.
The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA) to improve the efficiency and timeliness of FDA’s 510(k) process. Under the program, FDA accredits third parties (Accredited Persons) that are authorized to conduct the primary review of 510(k)s for eligible devices. Under MDUFA IV, the FDA committed to publishing the performance of individual accredited Third Parties with at least five completed submissions on the Web (e.g., rate of NSE, average number of holds, average time to SE).