Food and Drug Administration: Data to Measure the Timeliness of Reviews of Medical Device Applications are Limited : Report to Congressional Committees
United States Government Accountability Office, 2004 - Medical instruments and apparatus - 26 pages
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MDUFMA Performance Goals for Fiscal Years 2003
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20 performance goals 2005 MDUFMA performance activities and inspections agency's performance amendment contains application Cycle action application FDA applications received approvable letter pending approvable pending GMP approvable pending minor approving the application CDRH complete response corrections or clarifications days 70 decision letter approval deficiency letter requesting device compliance activities device is substantially established time frame Expedited PMAs FDA must meet FDA took actions fiscal year 2003 goal's established goals for fiscal Government Accountability Office inspections of manufacturers Issue decision letter letter pending minor letter requesting significant major deficiency letter Mammography March 31 Marcia Crosse MDUFMA performance goals medical device applications medical device compliance nonclinical studies Original PMAs Panel-Track Supplements pending GMP inspection pending minor corrections Percentage of actions performance data performance goal applies PMA review process Premarket Reports product recalls requesting significant information reviews applications safety and effectiveness substantially equivalent taken on applications taking a cycle types of applications