Status of FDAs Program for Inspections by Accredited Organizations

January 2007 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 . . .