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U.S. Department of Health and Human Services

Medical Devices

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Agenda and Materials From August 4, 2009 FDA Performance Report

1:00 – 3:00, Tuesday, August 4, 2009
Room G514, Bldg 66, White Oak

Welcome. Kate Cook, CDRH-OCD.

Guidance Development

  • Discussion of case study: Binita Asher, CDRH-ODE.
  • FDA issued 2 medical device guidance documents during the second quarter.
    Barbara Zimmerman, CDRH-ODE; Leonard Wilson, CBER; Don St. Pierre, CDRH-OIVD
  • Developing guidance priorities for FY 2010:  Kate Cook, CDRH-OCD.

FDA MDUFMA / MDUFA Performance — Actions through June 30, 2009

  • Reports on all decision goals for the FY 2003 - FY 2009 cohorts.
    • CBER: Leonard Wilson , CBER.
    • CDRH: Barbara Zimmerman, ODE.
    • Reports on total time to market for FY 2008 and FY 2009 cohorts.
      Barbara Zimmerman, CDRH-ODE.

CDRH’s Move to White Oak

  • Update on CDRH’s move to the White Oak campus.
    Barbara Zimmerman, CDRH-ODE.

Qualitative Update on Finances and Use of Resources — As of end of Q3, FY 2009

  • User fee receipts for the first nine months of FY 2009, compared with expectations.
    David Miller, FDA-OFM.
  • FY 2009/2010 Budget Requests and appropriations. Marjorie Waskewich, CDRH-OMO.


  • Questions from industry.
  • Set date for next meeting, following close of Q3. Target: Week of November 9-13 (November 11 is Veterans Day).
  • Logistics