MDUFMA: Agenda and Materials From April 20, 2010 FDA Performance Report
Tue, 06/15/2010 - 5:35am
Welcome. Barbara Zimmerman, CDRH-ODE.
- 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.
- 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 Ã¢?? 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.