MDUFMA: Agenda and Materials From April 20, 2010 FDA Performance Report

Welcome. Barbara Zimmerman, CDRH-ODE.

Guidance Development

• FDA issued 1 medical device guidance document during the second quarter. Barbara Zimmerman, CDRH-ODE; Leonard Wilson, CBER; Don St. Pierre, CDRH-OIVD

Strategic Plan Update

• Transparency Initiative update. Barbara Zimmerman, CDRH-ODE

FDA MDUFMA / MDUFA Performance – Actions through March 31, 2010

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

Registration Update

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

Training

• FY 2010 MDUFA-related training – Laura Stewart, CDRH-OCER-Staff College

Qualitative Update on Finances and Use of Resources â?? 2st Quarter of FY 2010

• User fee receipts through the 1st 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 7/27/2010.

    

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