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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
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MDUFMA Update Guidance, FR Notices Performance/Process changes Implementation Planned reports
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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
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FR Notices User fee payment procedures Establishment of a public docket 02N-0534 Send comments electronically
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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 Device Receipts & Performance
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CBER Process Changes New document courier service Close collaboration with CDRH Least Burdensome training Active problem solving during first cycle
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Implementation Basic reference materials on Website Office of Combination Products Guidance under rapid development Outreach April 9 live satellite broadcast and Webcast
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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
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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
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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
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Please let us know Your concerns Problems we need to solve
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