Agenda and Materials From January 26, 2010 FDA Performance Report

1:00 – 3:00, Tuesday, January 26, 2010
Room G514, Bldg 66, White Oak

Welcome. Barbara Zimmerman, CDRH-ODE.

Guidance Development

• FDA issued 10 medical device guidance documents during the first quarter.
  Barbara Zimmerman, CDRH-ODE; Leonard Wilson, CBER; Don St. Pierre, CDRH-OIVD

Unique Device Identification Progress

• Report on the progress of the Agency to implement a Unique Device Identification system, Jim Norman, OCD.

FDA MDUFMA / MDUFA Performance — Actions through December 31, 2009

• Reports on all decision goals for the FY 2003 - FY 2010 cohorts.
  • CBER: Leonard Wilson , CBER.
  • CDRH: Barbara Zimmerman, CDRH.
• Total Time for Review
  • CBER: Leonard Wilson, CBER
  • CDRH: Barbara Zimmerman, CDRH.

CLIA Waiver Review Times

• Report on qualitative goals and number of pending waiver requests, Don St. Pierre, CDRH-OIVD.

Qualitative Update on Finances and Use of Resources — 1 st Quarter of FY 2010

• User fee receipts through the 1 st 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 4/27/2010.