Update medical device user fee and modernization act of 2002
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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. 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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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

MDUFMA Update

  • Guidance, FR Notices

  • Performance/Process changes

  • Implementation

  • Planned reports


Guidance published

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

FR Notices

  • User fee payment procedures

  • Establishment of a public docket

    • 02N-0534

    • Send comments electronically


Device receipts performance

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


Cber process changes

CBER Process Changes

  • New document courier service

  • Close collaboration with CDRH

  • Least Burdensome training

  • Active problem solving during first cycle


Implementation

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

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

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

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:

    [email protected]


Please let us know

Please let us know

  • Your concerns

  • Problems we need to solve


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