Third Party Review
What is Third Party Review?
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 implemented an expansion pilot in January 2001 that allows Accredited Persons to review many Class II devices that were not previously eligible. The 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 a guidance document entitled, Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997 (listed below). This guidance is a revision of the October 30, 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.
During fiscal year 2002, 510(k)'s reviewed by Accredited Persons received FDA marketing clearance in an average of 77 days after initial receipt by the Accredited Person--29% faster than comparable 510(k)'s reviewed entirely by FDA. In addition, submissions reviewed by Accredited Persons are not subject to FDA user fees, while 510(k)'s sent directly to FDA are subject to a fee of $2,187 in fiscal year 2003. Most Accredited Persons have specialized expertise in areas that may be helpful to 510(k) submitters, such as device testing, standards, or foreign regulatory requirements. Further, Accredited Persons have headquarters throughout the United States, in Europe, and in Taiwan, and have additional offices elsewhere, so they often can provide local service