United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2008-01-29 monographic deposited born digital 30 p. GA 1.13:GAO-08-428T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-428T P0b002ee180391f3d f:d08428t DGPO 2010-08-12 2011-03-28 GAOREPORTS-GAO-08-428T machine generated eng fdlp REPORT GAOREPORTS-GAO-08-428T GAO-08-428T Certification and accreditation Eligibility determinations Evaluation criteria Inspection Institution accreditation Manufacturing industry Medical equipment Program evaluation Quality control Schedule slippages Voluntary compliance FDA Inspection By Accredited Persons Program Testimony A80232 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. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-428T/html/GAOREPORTS-GAO-08-428T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-428T/pdf/GAOREPORTS-GAO-08-428T.pdf GAO-08-428T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-428T Testimony GAO-08-428T; Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections; Certification and accreditation Eligibility determinations Evaluation criteria Inspection Institution accreditation Manufacturing industry Medical equipment Program evaluation Quality control Schedule slippages Voluntary compliance FDA Inspection By Accredited Persons Program Volume 116 Page 1588 116 Stat. 1588 Volume 121 Page 858 121 Stat. 858 Public Law 107-250 Public Law 110-85