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 2008-05-14 monographic deposited born digital 26 p. GA 1.13:GAO-08-780T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-780T P0b002ee1803849da f:d08780t DGPO 2010-08-12 2011-03-28 GAOREPORTS-GAO-08-780T machine generated eng fdlp REPORT GAOREPORTS-GAO-08-780T GAO-08-780T Accountability Certification and accreditation Data integrity Databases Food and drug legislation Foreign governments Importing Inspection International cooperation International relations Investigations by federal agencies Manufacturing industry Medical equipment Product evaluation Program evaluation Program management Quality control Risk assessment Program goals or objectives Testimony A82110 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 certain foreign and domestic 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 voluntary programs for that purpose. This statement is based primarily on GAO testimonies from January 2008 (GAO-08-428T) and April 2008 (GAO-08-701T). In this statement, GAO assesses (1) FDA's program for inspecting foreign establishments that manufacture medical devices for the U.S. market and (2) FDA's programs for third-party inspections of those establishments. For GAO's January and April 2008 testimonies, GAO interviewed FDA officials, analyzed information from FDA, and updated GAO's previous work on FDA's programs for inspections by accredited third parties. GAO updated selected information for this statement in early May 2008. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-780T/html/GAOREPORTS-GAO-08-780T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-780T/pdf/GAOREPORTS-GAO-08-780T.pdf GAO-08-780T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-780T Testimony GAO-08-780T; Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments; Accountability Certification and accreditation Data integrity Databases Food and drug legislation Foreign governments Importing Inspection International cooperation International relations Investigations by federal agencies Manufacturing industry Medical equipment Product evaluation Program evaluation Program management Quality control Risk assessment Program goals or objectives Volume 116 Page 1588 116 Stat. 1588 Volume 121 Page 823 121 Stat. 823 Public Law 107-250 Public Law 110-85