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


  • 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.


  • Questions from industry.
  • Set date for next meeting, following close of Q2. Target: Week of 7/27/2010.