Agenda and Materials From July 29, 2010 FDA Performance Report

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

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• Agenda
• Meeting Materials

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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.