About FDA

Expedited Original PMAs and Panel-Track PMA Supplements

FY 2009 MDUFA Performance Report Table of Contents


The table below summarizes the Tier 1 and Tier 2 performance goals for expedited original PMAs and panel-track PMA supplements. Performance goals are applied to the MDUFA cohort submissions.

GoalTierReview TimePerformance Level
FY 2008 – FY 2012 Submissions
Issue a decision for expedited
filed submissions
1180 days50% on time
2280 days90% on time



The number of expedited PMA and panel-track PMA supplement MDUFA cohort submissions decreased in FY 2009 to the same number of submissions received in FY 2006 and FY 2007 (see corresponding graph and table). 

Expedited PMAs, Panel-Track PMA Supplements, and Premarket Reports MDUFA FY 2009

Expedited PMAs and Panel-Track PMA Supplements

TypeFY 05FY 06FY 07FY 08FY 09
MDUFA Cohort Submissions*62242

* Only workload for expedited PMAs was reported on from FY 2005 through FY 2007. Workload for expedited panel-track PMA supplements was not reported during this time and not required under MDUFMA I. 



As of September 30, 2009, performance data was available for all (4 of 4) of expedited filed FY 2008 submissions and half (1 of 2) of FY 2009 submissions (see table below). The total number of expedited filed submissions received for the FY 2008 (four) and FY 2009 (two) cohorts combined is less than ten. When this occurs, FDA will present on-time review performance but will delay reporting on performance with respect to performance goals until combined consecutive cohort numbers reach a total of ten submissions.[7].

  • FDA met the Tier 1 review-time goal for 1 of 4 submissions in FY 2008 and did not meet the Tier 1 review-time goal for the single submission in FY 2009.
  • FDA met the Tier 2 review-time goal for 2 of 3 submissions in FY 2008.
GoalTier Performance
Fiscal YearCohort ClosedReceivedPending
Within Goal
OverdueOn TimePercent
On Time
Issue a decision for expedited filed submissions1Issue 50% within
180 days
2Issue 90% within
280 days

[7]When the number of submissions granted expedited review is less than ten in any one fiscal year, FDA combines the submissions for the following fiscal year(s) in order to form a cohort of ten submissions upon which FDA is then held to the performance goals.

Next page: PMA Modules

Page Last Updated: 09/09/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English