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U.S. Department of Health and Human Services

Medical Devices

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Agenda and Materials From January 26, 2010 FDA Performance Report

1:00 – 3:00, Tuesday, January 26, 2010
Room G514, Bldg 66, White Oak

Welcome. Barbara Zimmerman, CDRH-ODE.

Guidance Development

  • FDA issued 10 medical device guidance documents during the first quarter.
    Barbara Zimmerman, CDRH-ODE; Leonard Wilson, CBER; Don St. Pierre, CDRH-OIVD

Unique Device Identification Progress

  • Report on the progress of the Agency to implement a Unique Device Identification system, Jim Norman, OCD.

FDA MDUFMA / MDUFA Performance — Actions through December 31, 2009

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

CLIA Waiver Review Times

  • Report on qualitative goals and number of pending waiver requests, Don St. Pierre, CDRH-OIVD.

Qualitative Update on Finances and Use of Resources — 1 st Quarter of FY 2010

  • User fee receipts through the 1 st 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 4/27/2010.