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MDUFMA Stakeholders Meeting – Performance Goals November 17, 2005

MDUFMA Stakeholders Meeting – Performance Goals November 17, 2005. Marlene Valenti, Vice President of Regulatory Affairs, Cordis Corporation. Performance Goals. Mandated under 2002 Medical Device User Fee and Modernization Act (MDUFMA)

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MDUFMA Stakeholders Meeting – Performance Goals November 17, 2005

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  1. MDUFMA Stakeholders Meeting – Performance GoalsNovember 17, 2005 Marlene Valenti, Vice President of Regulatory Affairs, Cordis Corporation

  2. Performance Goals • Mandated under 2002 Medical Device User Fee and Modernization Act (MDUFMA) • Intent was to reduce the amount of time from submission to market • Includes decision goals and cycle goals • FDA met most of 2005 Performance Goals • AdvaMed commends FDA for this achievement

  3. Performance Goals • Does Current Process Achieve the Original Intent? • FDA Response: In some cases and some cases unintended consequences • Industry Response: Very Infrequently

  4. Industry Perspective Substantial increase in non-approvable letters for PMA Supplements FY 2003: 31 out of 203 or ~ 15% FY 2004: 43 out of 103 or ~ 42% FY 2005: Not available, suspect it may be higher Increase in not-substantially equivalent (NSE’s) decisions for 510 (k) submissions Performance Goals

  5. Performance Goals • Path Forward • More guidance documents needed • Release of PMA Change Guidance document will provide transparency on what type of submission is required • AdvaMed willing to work in a collaborative manner to develop innovative ways to improve process

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