Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections

As part of the Food and Drug Administration's (FDA) oversight of the safety and effectiveness of medical devices marketed in the United States, it inspects domestic and foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. GAO previously reported on the status of one of these programs, citing concerns regarding its implementation and factors that may influence manufacturers' participation. (Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations, GAO-07-157, January 2007.) This statement (1) assesses FDA's management of inspections of establishments--particularly those in foreign countries--manufacturing devices for the U.S. market, and (2) provides the status of FDA's programs for third-party inspections of medical device manufacturing establishments. GAO interviewed FDA officials; reviewed pertinent statutes, regulations, guidance, and reports; and analyzed information from FDA databases. GAO also updated its previous work on FDA's programs for inspections by accredited third parties.