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Transition Period (FY 2007)

FY 2009 MDUFA Performance Report Table of Contents

The FY 2007 cohort served as a transition period from MDUFMA I to MDUFA II as many submissions received in FY 2007 (during MDUFMA I) were acted on or due for action in FY 2008 (during MDUFA II). FDA will continue to report on MDUFMA I decision goals for submissions received in FY 2007 until performance can be reported as final. FY 2007 decision goals for standard original biologics licensing applications (BLAs) and BLA manufacturing supplements that require prior approval had final performance reported in the FY 2008 MDUFA Performance Report and, therefore, are not included in this, or future, MDUFA performance reports.
 
Performance for FY 2007
 
The table below finalizes FDA’s performance on the MDUFMA I cohort for FY 2007 as of September 30, 2009. Overall, FDA met or exceeded 3 of 5 performance goals for FY 2007.
  • PMAs, Panel-Track Supplements, and Premarket Reports. FDA completed 54 percent (20 of 37) of reviews (to make a decision within 180 days) on time and exceeded the 50 percent performance goal. FDA completed 87 percent (32 of 37) of reviews (to make a decision within 320 days) on time and did not meet the 90 percent performance goal.
  • Expedited PMAs. FDA did not complete either of the two reviews on time and did not meet the 90 percent performance goal.
  • 180-day PMA Supplements. FDA completed 92 percent (130 of 142) of reviews on time and exceeded the 90 percent performance goal.
  • 510(k)s. FDA completed 91 percent (2,940 of 3,238) of reviews on time and exceeded the 80 percent performance goal.

PMAs, Panel-Track Supplements, and Premarket Reports

GoalsReview WithinCohort ClosedReceived*Final Performance
OverdueOn TimePercent
On Time
Performance Goal
Make an “FDA decision”180 daysN37172054%50%
320 daysN3753287%90%

Expedited PMAs

GoalsReview WithinCohort ClosedReceived*Final Performance
OverdueOn TimePercent
On Time
Performance Goal
Make an “FDA decision”300 daysY2200%90%

180-day PMA Supplements

GoalsReview WithinCohort ClosedReceived*Final Performance
OverdueOn TimePercent
On Time
Performance Goal
Make an “FDA decision”180 daysY1421213092%90%

510(k)s

GoalsReview WithinCohort ClosedReceived*Final Performance
OverdueOn TimePercent
On Time
Performance Goal
Make a SE or NSE decision90 daysN3,2382982,94091%80%

* The data shown for 510(k)s received represents the MDUFMA cohort. The MDUFMA cohort for 510(k)s excludes submissions that were closed for any reason other than an SE or NSE decision. Each MDUFMA cohort count is subject to change until that cohort is closed.

Next page: Report on MDUFA II Performance Goals