About FDA

180-Day PMA Supplements

FY 2009 MDUFA Performance Report Table of Contents

Goals

The table below summarizes the Tier 1 and Tier 2 performance goals for 180-day PMA supplements. Performance goals are applied to the MDUFA cohort submissions.
 

GoalTierReview TimePerformance Level
FY 2008 – FY 2012 Submissions
Issue a decision for 180-day PMA supplements1180 days85% on time
2210 days95% on time

 

Workload

The number of 180-day PMA supplement MDUFA cohort submissions reached a 4-year high in FY 2008 and remained at that level in FY 2009 (see corresponding graph and table).

180-Day PMA Supplements MDUFA FY 2009

 

180-Day PMA Supplements

TypeFY 05FY 06FY 07FY 08FY 09
Submissions101137142175170
MDUFA Cohort Submissions101137142167*167

* FY 2008 number was updated to reflect a correction to the FY 2008 MDUFA Performance Report.

 

Performance

As of September 30, 2009, performance data was available for virtually all (163 of 167) of the 180-day PMA supplement FY 2008 submissions and half (83 of 167) of FY 2009 submissions (see table below).

  • FDA met the Tier 1 review-time goal for 147 of 163 submissions in FY 2008 and 80 of 83 submissions in FY 2009. With submissions pending within goal, FDA has the potential to exceed the Tier 1 performance goal for FY 2008 and FY 2009.
  • FDA met the Tier 2 review-time goal for 156 of 163 submissions in FY 2008 and all (81 of 81) submissions in FY 2009. With submissions pending within goal, FDA has the potential to exceed the Tier 2 performance goal for FY 2008 and FY 2009.
GoalTier Performance
Goals
Fiscal YearCohort ClosedReceivedPending
Within Goal
OverdueOn TimePercent
On Time
Issue a decision for 180-day PMA supplements1Issue 85% within
180 days
2008N16741614790%
2009N1678438096%
2Issue 95% within
210 days
2008N1674715696%
2009N16786081100%

Next page: Real-Time PMA Supplements

Page Last Updated: 09/09/2015
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