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U.S. Department of Health and Human Services

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PMA Modules

Goals

The table below summarizes the Tier 1 and Tier 2 performance goals for PMA modules.[8]  PMA modules are discrete sections of the PMA that can be submitted and reviewed independently prior to the complete PMA submission. When a module is submitted or when additional information on a module is received, a review cycle on that module begins. The cycle ends when FDA takes an action, including acceptance of the module, request for additional information, and withdrawal from the sponsor. The review-time goal for PMA modules specifies the amount of time in days that an action must be taken on module cycles to be counted as on time. The performance level specifies the percentage of module cycles submitted in a given fiscal year that FDA must take action on within the review-time goal to meet the performance goal. Performance goals are applied to the MDUFA review cycles.

Goal Tier Review Time Performance Level
FY 2008 – FY 2012 Submissions
Take action on PMA modules 1 90 days 75% on time
2 120 days 90% on time

 

Workload

The number of PMA modules increased by over half from FY 2008 to FY 2009. However, the number of MDUFA review cycles for these PMA modules increased by over two-thirds (see corresponding graph and table).

PMA Modules MDUFA FY 2009

PMA Modules

Type FY 05 FY 06 FY 07 FY 08 FY 09
Modules -- -- -- 43 68
Review Cycles -- -- -- 55 89
MDUFA Review Cycles* -- -- -- 47 79

* Workload for PMA modules was not reported for FY 2005 through FY 2007 and not required under MDUFMA I.

Performance

As of September 30, 2009, performance data was available for all (47 of 47) PMA module FY 2008 review cycles and over four-fifths (65 of 79) of FY 2009 review cycles (see table below).

  • FDA completed 49 percent (23 of 47) of review cycles on time and did not meet the Tier 1 performance goal for FY 2008. FDA met the Tier 1 review-time goal for 40 of 65 review cycles in FY 2009. With cycles pending within goal, FDA can improve performance, but cannot meet the Tier 1 performance goal for FY 2009.
  • FDA completed 87 percent (41 of 47) of review cycles on time and did not meet the Tier 2 performance goal for FY 2008. FDA met the Tier 2 review-time goal for 52 of 57 review cycles in FY 2009. With cycles pending within goal, FDA has the potential to exceed the Tier 2 performance goal for FY 2009.
Goal Tier Performance
Goals
Fiscal Year Cohort Closed Review Cycles Started Pending
Within Goal
Overdue On Time Percent
On Time
Take action on
PMA modules
1 Act on 75% within
90 days
2008 Y 47 0 24 23 49%
2009 N 79 14 25 40 62%
2 Act on 90% within
120 days
2008 Y 47 0 6 41 87%
2009 N 79 22 5 52 91%

[8] See Premarket Approval Application Modular Review – Guidance for Industry and FDA Staff for more information.

Next page: 180-Day PMA Supplements MDUFA FY 2009