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Performance for MDUFMA I Cohorts for FY 2004 through FY 2006

FY 2009 MDUFA Performance Report Table of Contents

The table below presents FDA’s final performance on the MDUFMA I cohorts for FY 2004 through FY 2006 as of September 30, 2009. Although percent-on-time performance is provided for FY 2004 and for FY 2005 PMAs, Panel-Track Supplements, and Premarket Reports based on review-time targets, performance goals were not established for these submissions. Overall, FDA met or exceeded 5 of 7 performance goals established for FY 2005 and FY 2006.

  • PMAs, Panel-Track Supplements, and Premarket Reports. FDA completed 77 percent (43 of 56) of reviews on time in FY 2006 and did not meet the 80 percent performance goal.
  • Expedited PMAs. FDA completed 83 percent (5 of 6) of reviews on time in FY 2005, and exceeded the 70 percent performance goal. In FY 2006, FDA completed 50 percent (1 of 2) of reviews on time and did not meet the 80 percent performance goal.
  • 180-day PMA Supplements. FDA completed 95 percent (96 of 101) of reviews on time in FY 2005 and exceeded the 80 percent performance goal. In FY 2006, FDA completed 96 percent (131 of 137) of reviews on time and, again, exceeded the 80 percent performance goal.
  • 510(k)s. FDA completed 91 percent (3,100 of 3,401) of reviews on time in FY 2005 and exceeded the 75 percent performance goal. In FY 2006, FDA, again, completed 91 percent (3,199 of 3,503) of reviews on time and, again, exceeded the 75 percent performance goal.

PMAs, Panel-Track Supplements, and Premarket Reports

GoalReview WithinFiscal YearCohort ClosedReceived*Final Performance
OverdueOn TimePercent On TimePerformance Goal
Make an “FDA decision”320 days2004Y4844492%No Goal
2005N5784986%No Goal
2006N56134377%80%

Expedited PMAs

GoalReview WithinFiscal YearCohort ClosedReceived*Final Performance
OverdueOn TimePercent On TimePerformance Goal
Make an “FDA decision”300 days2004N1421286%No Goal
2005Y61583%70%
2006Y21150%80%

180-day PMA Supplements

GoalReview WithinFiscal YearCohort ClosedReceived*Final Performance
OverdueOn TimePercent On TimePerformance Goal
Make an “FDA decision”180 days2004Y106510195%No Goal
2005Y10159695%80%
2006N137613196%80%

510(k)s

GoalReview WithinFiscal YearCohort ClosedReceived*Final Performance
OverdueOn TimePercent On TimePerformance Goal
Make a “substantially equivalent” (SE) or “not substantially equivalent” (NSE) decision90 days2004Y3,3815462,83584%No Goal
2005Y3,4013013,10091%75%
2006N3,5033043,19991%75%

* 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.

* 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: Transition Period (FY 2007)