Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments: Congressional Testimony
DIANE Publishing, 2008 - 22 pages
As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., 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 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.
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According to FDA accredited organization Accredited Persons Inspection accredited third parties affected entities agency agency’s assess class of device conduct inspections conducted through FDA’s defibrillators device establishment inspections device manufacturing establishments domestic establishments DRLS eligibility establishments manufacturing medical establishments subject establishments that manufacture FDA conduct FDA inspects FDA’s programs FDAAA fiscal year 2007 foreign establishments manufacturing foreign inspections foreign medical device Health Canada identification number implementation inspect foreign establishments inspections by accredited inspections conducted inspections of establishments inspections of foreign January 2008 statement manufacture class manufacture medical devices manufacturing practices MDUFMA medical device establishments medical device inspection medical device manufacturing number of foreign number of inspections number of registered OASIS obtained information organization to conduct participation Persons Inspection Program postmarket inspections postmarket quality system potential incentives premarket inspections program for inspecting quality system inspections registered establishments regulatory representatives of affected SEDS single inspection Taiwan third-party inspections third-party organizations U.S. market United