TITLE

Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations: GAO-07-157

AUTHOR(S)
Crosse, Marcia
PUB. DATE
January 2007
SOURCE
GAO Reports;1/5/2007, p1
SOURCE TYPE
Government Document
DOC. TYPE
Article
ABSTRACT
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. FDA granted accreditation to 17 of 23 organizations that applied to conduct inspections of establishments where medical devices are manufactured. FDA denied accreditation to applicants that did not meet minimum criteria because their applications were not correctly completed or did not demonstrate the applicants' technical competence. During the first accreditation year, which started in April 2003, FDA received 23 applications. Of the 23 applications, 2 were not correctly completed and 2 did not demonstrate that the applicants had adequate technical competence. Although the remaining 19 applicants met the minimum criteria, MDUFMA limited the number of organizations that could be accredited to 15 during the first year after FDA issued criteria for accreditation. FDA scored the 19 applications against these criteria and rank-ordered them. It accredited the 15 organizations with the highest ranking applications, but 1 organization later withdrew. After the initial accreditation year, FDA received 2 more applications for accreditation and it accredited both organizations. These 16 organizations remained accredited as of October 31, 2006. Between March 11, 2004, and October 31, 2006, two accredited organizations conducted independent inspections--one inspection of a domestic establishment and one inspection of a foreign establishment. During that same period, 36 inspections of domestic establishments and 1 inspection of a foreign establishment were conducted by accredited organizations jointly with FDA officials as part of training that FDA requires of accredited organizations. As of October 31, 2006, individuals from 7 of the...
ACCESSION #
23684516

 

Related Articles

  • Food and Drug Administration: Data to Measure the Timeliness of Reviews of Medical Device Applications Are Limited: GAO-04-1022. Crosse, Marcia // GAO Reports;8/30/2004, p1 

    FDA reviews applications from manufacturers that wish to market medical devices in the United States. To ensure prompt approval of new devices and clearance of devices that are substantially equivalent to those legally on the market, the Congress passed the Medical Device User Fee and...

  • GAO files follow-up to FDA report.  // Medical Device Daily;6/22/2009, Vol. 13 Issue 118, p2 

    The article focuses on a report filed by the U.S. Government Accountability Office (GAO) which is a follow up of its January 2009 report about the medical device approval process of the U.S. Food and Drug Administration (FDA). It notes that the report did not give the FDA a much higher rating...

  • GAO: 3rd-party audit program for devices seems stuck in 1st gear. McCarty, Mark // Medical Device Daily;1/31/2008, Vol. 12 Issue 21, p1 

    This article presents information on a report released by the U.S. Government Accountability Office regarding device inspections being made by the U.S. Food and Drug Administration (FDA). The report revealed that the FDA is having a brutal time keeping up with inspections .The report was...

  • Rx News FDA, Politics, and Public Protection.  // HealthFacts;Dec2002, Vol. 27 Issue 12, p4 

    Focuses on the role of the government in assuring the safety and efficacy of medical products in the U.S. Responsibilities of the U.S. Food and Drug Administration; Details on the political activities of drug manufacturers; Discussion on medical device user fees in the U.S.

  • MEDICAL DEVICES: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments. Crosse, Marcia // GAO Reports;6/18/2009, preceding p1 

    The article presents a report by the U.S. Government Accountability Office (GAO) on the shortcomings in Food & Drug Administration's (FDA) premarket review, postmarket surveillance and inspections of device manufacturing establishments. It is reported that FDA is responsible for the safety of...

  • MEDICAL DEVICES, FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer.  // GAO Reports;3/29/2012, preceding p1 

    The article discusses the report of the U.S. Government Accountability Office (GAO) on the performance of the Food and Drug Administration (FDA), responsible for monitoring the effectiveness of medical devices sold in the U.S. The GAO reported that FDA takes longer review time than expected and...

  • $595M user fee agreement will measure by total review times. McCarty, Mark // Medical Device Daily;2/2/2012, Vol. 16 Issue 22, p1 

    This article reports on a user fee agreement for medical devices agreed by the U.S. Food and Drug Administration (FDA) and the medical device industry in 2012. The FDA will receive less than 290 U.S. dollars. The agency entered the agreement following complaints that reviewers were asking for...

  • FDA, industry agree to apply user fees to guidance docs. McCARTY, MARK // Medical Device Daily;11/18/2011, Vol. 15 Issue 222, p1 

    This article reports on the negotiations between the U.S. Food and Drug Administration (FDA) and the medical device industry for the third five-year device user fee schedule in 2011. The industry expressed its support for the intention of the FDA to divert user fees to nudge guidance document...

  • Picking up the pace. Becker, Cinda // Modern Healthcare;10/28/2002, Vol. 32 Issue 43, p12 

    Focuses on a legislation passed by the U.S. Congress on the approval process for medical devices at the Food and Drug Administration. Details of the legislation; Information on third-party reprocessors of devices designed for single-use only; Discussion on medical device user fees.

Share

Read the Article

Other Topics