Medical Devices
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Agenda and Materials From April 20, 2010 FDA Performance Report
1:00 - 3:00, Tuesday, April 20, 2010
Room G514, Bldg 66, White Oak
W Barbara Zimmerman, CDRH-ODE.elcome.
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 — 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.
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Meeting Materials
CDRH Overview (MDUFMA FDA Performance Report April 20, 2010) (PDF - 193KB)CBER Overview (MDUFMA FDA Performance Report April 20, 2010) (PDF - 128KB)Medical Device Guidance Documents Issued During FY2010 through March 31, 2010 (MDUFMA FDA Performance Report April 20, 2010) FY 2010 Medical Device User Fee Collections as of March 31, 2010 (MDUFMA FDA Performance Report April 20, 2010) (PDF - 22KB)FY 2010 Staff College Internal Training Summary Report as of March 31, 2010 (MDUFMA FDA Performance Report April 20, 2010) (PDF - 131KB)Medical Device Registration and Listing Statistics (MDUFMA FDA Performance Report April 20, 2010)
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