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MDUFMA: Agenda and Materials From April 20, 2010 FDA Performance Report

June 15, 2010 By U.S. Food & Drug Administration

Welcome. Barbara Zimmerman, CDRH-ODE.

Guidance Development

  • FDA issued 1 medical device guidance document during the second quarter. Barbara Zimmerman, CDRH-ODE; Leonard Wilson, CBER; Don St. Pierre, CDRH-OIVD

Strategic Plan Update

  • Transparency Initiative update. Barbara Zimmerman, CDRH-ODE

FDA MDUFMA / MDUFA Performance – Actions through March 31, 2010

  • Reports on all decision goals for the FY 2003 – FY 2010 cohorts.
    • CBER: Leonard Wilson, CBER.
    • CDRH: Barbara Zimmerman, CDRH.

Registration Update

  • Number of Device establishments registered and by type. David Racine, CDRH-OC

Training

  • FY 2010 MDUFA-related training – Laura Stewart, CDRH-OCER-Staff College

Qualitative Update on Finances and Use of Resources â?? 2st Quarter of FY 2010

  • User fee receipts through the 1st Quarter of FY 2010, compared with expectations. David Miller, FDA-OFM.
  • Update on Budget Requests and appropriations. Daniel Montgomery, CDRH-OMO.

Discussion

  • Questions from industry.
  • Set date for next meeting, following close of Q2. Target: Week of 7/27/2010.

    

SOURCE

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  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
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    • Tubing
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    • Subscribe to Print Magazine
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    • Manufacturer Search
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    • Print Subscription
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