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U.S. Department of Health and Human Services

Medical Devices

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Agenda and Materials From July 29, 2010 FDA Performance Report

1:00 - 3:00, Thursday, July 29, 2010
Room G512, Bldg 66, White Oak



Welcome. Barbara Zimmerman, CDRH-ODE.

MDUFA Renegotiation

  • Malcolm Bertoni will lead discussion on the Agency’s thoughts.

Guidance Development

  • FDA issued 7 medical device guidance document during the second quarter.
    Barbara Zimmerman, CDRH-ODE; Kate Cook, CBER; Don St. Pierre, CDRH-OIVD

FDA MDUFMA / MDUFA Performance — Actions through June 30, 2010

  • Reports on all decision goals for the FY 2003 - FY 2010 cohorts.
    • CBER: Kate Cook , CBER.
    • CDRH: Barbara Zimmerman, CDRH.

Registration Update

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

Qualitative Update on Finances and Use of Resources — 3 rd Quarter of FY 2010

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

CDRH Update

  • Barbara Zimmerman will provide additional CDRH updates.

Discussion

  • Questions from industry.
  • Set date for next meeting, following close of Q4. Target: Week of 10/25/2010.