Agenda and Materials From July 29, 2010 FDA Performance Report
1:00 - 3:00, Thursday, July 29, 2010
Room G512, Bldg 66, White Oak
Welcome: Barbara Zimmerman, CDRH-ODE.
- Malcolm Bertoni will lead discussion on the Agency’s thoughts.
- FDA issued 7 medical device guidance document during the second quarter.
Barbara Zimmerman, CDRH-ODE; Kate Cook, CBER; Don St. Pierre, CDRH-OIVD
FDA MDUFMA / MDUFA Performance — Actions through June 30, 2010
- Reports on all decision goals for the FY 2003 - FY 2010 cohorts.
- CBER: Kate Cook , CBER.
- CDRH: Barbara Zimmerman, CDRH.
- Number of Device establishments registered and by type. David Racine, CDRH-OC
Qualitative Update on Finances and Use of Resources — 3 rd Quarter of FY 2010
- User fee receipts through the 1 st Quarter of FY 2010, compared with expectations. Handout, FDA-OFM.
- Update on Budget Requests and appropriations. Daniel Montgomery, CDRH-OMO.
- Barbara Zimmerman will provide additional CDRH updates.
- Questions from industry.
- Set date for next meeting, following close of Q4. Target: Week of 10/25/2010.
CDRH Overview (MDUFMA FDA Performance Report July 29, 2010)(PDF - 311KB) CBER Overview (MDUFMA FDA Performance Report July 29, 2010)(PDF - 109KB) Medical Device Guidance Documents Issued During FY2010 through June 30, 2010 (MDUFMA FDA Performance Report July 29, 2010) FY 2010 Medical Device User Fee Collections as of June 30, 2010 (MDUFMA FDA Performance Report July 29, 2010)(PDF - 39KB) Medical Device Registration and Listing Statistics (MDUFMA FDA Performance Report July 29, 2010)