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U.S. Department of Health and Human Services

Medical Devices

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Agenda and Materials From November 17, 2009 FDA Performance Report

1:00 – 3:00, Tuesday, November 17th, 2009
Room 5425, Bldg 66, White Oak

Welcome. Barbara Zimmerman, CDRH-ODE.

Guidance Development

  • FDA issued 3 medical device guidance documents during the second quarter.
    Barbara Zimmerman, CDRH-ODE; Leonard Wilson, CBER; Don St. Pierre, CDRH-OIVD

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

  • Reports on all decision goals for the FY 2003 - FY 2009 cohorts.
    • CBER: Leonard Wilson , CBER.
    • CDRH: Barbara Zimmerman, ODE.

CLIA Waiver Review Times

  • Paragraph I.N.4 of the October 27, 2007 commitment letter calls for FDA to track review times for CLIA waiver applications, and to share this information with industry annually. This report covers FY 2009. Don St. Pierre, CDRH-OIVD.

Qualitative Update on Finances and Use of Resources — End of FY 2009

  • User fee receipts for FY 2009, compared with expectations.
    David Miller, FDA-OFM.
  • FY 2009/2010 Budget Requests and appropriations. Daniel Montgomery, CDRH-OMO.

Training

  • FY 2009 MDUFA-related training— Jackie Woodard, CDRH-OCER-Staff College

Discussion

  • Questions from industry.
  • Set date for next meeting, following close of Q1. Target: Week of 1/19/2010.
  • Logistics