Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations

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Description

A letter report issued by the Government Accountability Office with an abstract that begins "The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's 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 certain establishments where devices that are marketed in both the United States and other countries are manufactured. This report includes information that MDUFMA requires GAO to provide on (1) the number of organizations that ... continued below

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United States. Government Accountability Office. January 5, 2007.

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Description

A letter report issued by the Government Accountability Office with an abstract that begins "The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's 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 certain establishments where devices that are marketed in both the United States and other countries are manufactured. This report includes information that MDUFMA requires GAO to provide on (1) the number of organizations that sought accreditation, the number that were accredited, and reasons for denial of accreditation and (2) the number of inspections conducted by accredited organizations. It also includes information about factors that could influence manufacturers' interest in voluntarily requesting and paying for an inspection by an accredited organization. GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004--when FDA first cleared an accredited organization to conduct independent inspections--through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers."

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Government Accountability Office Reports

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for the U.S. Congress investigating how the federal government spends taxpayers' money. Its goal is to increase accountability and improve the performance of the federal government. The Government Accountability Office Reports Collection consists of over 13,000 documents on a variety of topics ranging from fiscal issues to international affairs.

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  • January 5, 2007

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  • June 12, 2014, 7:50 p.m.

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United States. Government Accountability Office. Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations, report, January 5, 2007; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc297446/: accessed April 28, 2017), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.