Third Party Review
- Expansion Pilot
- Accredited Person Performance Metrics
- Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews
The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA), based on an FDA pilot. The purpose of the program is to improve the efficiency and timeliness of FDA's 510(k) process, the process by which most medical devices receive marketing clearance in the United States. Under the program, FDA has accredited third parties (Accredited Persons) that are authorized to conduct the primary review of 510(k)s for eligible devices. Persons who are required to submit 510(k)s for these devices may elect to contract with an Accredited Person and submit a 510(k) directly to the Accredited Person. The Accredited Person conducts the primary review of the 510(k), then forwards its review, recommendation, and the 510(k) to FDA. By law, FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person. 510(k) submitters who do not wish to use an Accredited Person may submit their 510(k)s directly to FDA.
In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled, Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties (listed below). This guidance is a revision of the October 20, 1998, guidance document with the same title. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.
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). The most current Third Party Performance Metrics are available on our website.
The plan to eliminate FDA re-review of 510(k)'s provides information to ensure that third party review organizations are equipped to perform an FDA-equivalent review. The plan describes a comprehensive framework for FDA processing of third party 510(k) submission packages, and the plan further outlines the implementation of program monitoring activities authorized under FDARA to strengthen the program.