The table below summarizes the Tier 1 and Tier 2 performance goals for PMA modules. 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|
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).
|Type||FY 05||FY 06||FY 07||FY 08||FY 09|
|MDUFA Review Cycles*||--||--||--||47||79|
* Workload for PMA modules was not reported for FY 2005 through FY 2007 and not required under MDUFMA I.
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.
|Fiscal Year||Cohort Closed||Review Cycles Started||Pending|
|Overdue||On Time||Percent |
|Take action on|
|1||Act on 75% within |
|2||Act on 90% within |
 See Premarket Approval Application Modular Review – Guidance for Industry and FDA Staff for more information.
Next page: 180-Day PMA Supplements MDUFA FY 2009