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.
SOURCE
