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

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Presentation transcript:

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 Planned reports

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

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

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

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

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

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

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

How to Obtain Additional Information MDUFMA website for general guidance, reference materials, and new information: Send an to:

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