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Update: Medical Device User Fee and Modernization Act of 2002

Update: Medical Device User Fee and Modernization Act of 2002. Blood Products Advisory Committee March 13, 2003 Mary Elizabeth Jacobs, Ph.D. Associate Director for Regulatory Affairs OBRR, CBER. MDUFMA Update. Guidance, FR Notices Performance/Process changes Implementation

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Update: Medical Device User Fee and Modernization Act of 2002

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  1. Update: Medical Device User Fee and Modernization Act of 2002 Blood Products Advisory Committee March 13, 2003 Mary Elizabeth Jacobs, Ph.D. Associate Director for Regulatory Affairs OBRR, CBER

  2. MDUFMA Update • Guidance, FR Notices • Performance/Process changes • Implementation • Planned reports

  3. Guidance Published • PMA supplement definitions, modular PMA fees, BLA and Efficacy supplement definitions, bundling multiple devices in a single application, fees for combination products • Small business qualification

  4. FR Notices • User fee payment procedures • Establishment of a public docket • 02N-0534 • Send comments electronically

  5. Device Receipts & Performance FY03 PMAs (Traditional) 1 PMSs (180 Day) 1 510(k)s (All Types) 30 BLAs (Original, Std) 0 BLSs (Efficacy) 3 BLSs (Manufacturing, PAS)24 ALL MDUFMA FY 05 GOALS MET. Data as of 3/3/03

  6. CBER Process Changes • New document courier service • Close collaboration with CDRH • Least Burdensome training • Active problem solving during first cycle

  7. Implementation • Basic reference materials on Website • Office of Combination Products • Guidance under rapid development • Outreach • April 9 live satellite broadcast and Webcast

  8. MDUFMA Actions and Reports (CBER related) • April 24, 2003 • FDA: Criteria for third-party inspections • August 2, 2003 • FDA: information for pediatric devices • October 26, 2003 • FDA: accredit third-parties to conduct establishment inspections

  9. MDUFMA Actions(continued) • October 26, 2003 • FDA: Section 205 report to Congress on reviews by Centers other than CDRH • FDA: Report to Congress on the Office of Combination Products • November 30, 2003 • FDA: Annual report to Congress on progress in achieving performance goals

  10. How to Obtain Additional Information • MDUFMA website for general guidance, reference materials, and new information: www.fda.gov/cdrh/mdufma • Send an e-mail to: MDUFMA@cdrh.fda.gov

  11. Please let us know • Your concerns • Problems we need to solve

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