Originally Published MDDI January 2005

Regulatory Outlook

FDA's Third-Party Programs

Harvey Rudolph and John Stigi
Underwriters Laboratories Inc. and CDRH

The first pilot program included all Class I devices and selected Class II devices. Class II devices were allowed if the number of submissions per year was significant and if FDA guidance existed for the review. In 1997, this pilot program was written into law through the FDA Modernization Act (FDAMA). FDA accredited 14 third parties to review 510(k)s under the new Accredited Persons 510(k) Review (APR) program. Under the program, manufacturers could choose to pay a third party to review their submission. Manufacturers could still opt to have FDA do the review at no cost. One might wonder why manufacturers would willingly pay for something that was available at no charge, but the theory was that the free market would introduce efficiencies that would make the reviews occur more quickly. The law required FDA to make a determination on a third party's recommendation within 30 days to create a faster road to clearance that might be more attractive to manufacturers.

FDAMA's legislative history makes it clear that Congress expected FDA to expand the scope of devices eligible for third-party review. FDAMA excluded only Class III devices and the following Class II devices: permanently implantable, life sustaining or life supporting, and those that require clinical data in a 510(k).

FDA ultimately expanded the list of eligible devices to the full scope permitted by FDAMA, first by adding all allowable Class II devices for which FDA review guidance existed. In 2001, FDA added devices that do not have FDA review guidance. The sunset date for the APR program was extended to October 1, 2007, with the passage of the Medical Device User Fee and Modernization Act (MDUFMA) in 2002. More importantly, MDUFMA also established FDA user fees for 510(k)s that are submitted to FDA with no third-party review.

MDUFMA also introduced another third-party program, the Accredited Persons Inspection (API) program. Industry lobbied for the API program. Many manufacturers experience multiple visits from various regulatory authorities or conformity assessment bodies to inspect or audit their quality management systems. Ideally, combining these audits into a single regulatory audit would save the manufacturers and the regulatory bodies both time and money.
As an initial step in that direction, FDA has accredited and trained the first 14 accredited persons to perform regulatory device inspections. The agency is in the process of qualifying, via joint audits, these third parties. As in the APR program, manufacturers can choose to pay an accredited person to perform the inspection or wait for an FDA inspection.

FDA also administers another third-party program related to inspections and 510(k) reviews. This program is derived from the mutual recognition agreement (MRA) signed by the United States and the European Union (EU) in 1998. Under the MRA, the EU designates EU conformity assessment bodies (CABs) to perform FDA inspections for device manufacturers based in Europe that are marketing devices in the United States. The CABs are also trained and accredited to review 510(k)s for devices (which are listed in the MRA) that are produced in Europe for marketing in the United States. On the U.S. side, FDA designates U.S. CABs to audit firms that produce devices in the United States for marketing in Europe. These CABs are accredited to perform Annex II (complete quality assurance system) audits or Annex III (type examinations) audits that are acceptable to notified bodies in Europe.

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