These criteria were published in the Federal Register on April 28, 2003 at 68 FR 22400 and in the guidance "Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria."
During FY 2003, OHIP received 23 AP applications from 22 organizations. Because MDUFMA limits the number of APs to 15 in the first year, we prepared a “Rating and Ranking” checklist to assist in evaluation of the AP applications. After acceptance of the applications as well as formal classroom training and joint training inspections with the FDA, the approved APs will be able to conduct inspections in early FY 2004.
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.
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 FY 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.