1:00 - 3:00, Wednesday, October 27, 2010
Room G512, Bldg 66, White Oak
Welcome. Barbara Zimmerman, CDRH-ODE.
- FDA issued 11 medical device guidance documents during the fourth quarter.
Barbara Zimmerman, CDRH-ODE; Kate Cook, CBER; Don St. Pierre, CDRH-OIVD
FDA MDUFMA / MDUFA Performance — Actions through September 30, 2010
- Reports on all decision goals for the FY 2003 - FY 2010 cohorts.
- CBER: Kate Cook , CBER.
- CDRH: Barbara Zimmerman, CDRH.
Qualitative Update on Finances and Use of Resources — 4 th Quarter of FY 2010
- User fee receipts through the 1 st Quarter of FY 2010, compared with expectations.
Handout, David Miller, FDA-OFM.
- Update on Budget Requests and appropriations. Daniel Montgomery, CDRH-OMO.
- Barbara Zimmerman will provide an update on the Science and 510(k)s reports.
- Questions from industry.
- Set date for next meeting, following close of Q1. Target: Week of 1/24/2011.
- CDRH Overview (PDF - 205KB)
- CBER Overview (PDF - 109KB)
- Medical Device Guidance Documents Issued During FY2010 through September 30, 2010
- FY 2010 Medical Device User Fee Collections as of September 30, 2010 (PDF - 16KB)
- CLIA Waiver Decisions for FY2010
- Update on Use of Resources and Budget Requests
- Major Submissions Completed FY00 - FY09
- Total Review Times FY08 - FY10 (PDF - 26KB)
- Deidentified Average Review Times Data (PDF - 26KB)
- Numbers of Withdrawn or Deleted 510ks for FY05 - FY09 (PDF - 14KB)