Status of FDAs Program for Inspections by Accredited Organizations

The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDAs quality system requirements for ensuring good manufacturing practices and other applicable requirements. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required FDA to accredit organizations to inspect facilities that manufacture Class II and Class III devices marketed in the United States and other countries. This report includes the number of organizations that sought accreditation, received accreditation, and the number of inspections conducted by accredited organizations.

It also includes information about factors that could influence manufacturers interest in voluntarily requesting and paying for an inspection by an accredited organization. The barriers to wider adoption of such inspections included:

• Cost of an inspection FDA inspection is free
   
• Certainty of an inspection the FDA inspections, although potentially disruptive to the manufacturing process, occur infrequently over a five-year period because the FDA inspectors are backlogged
   
• Desire to wait until a preferred inspection organization is accredited by the FDA

GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004 when FDA first cleared an accredited organization to conduct independent inspections through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers.