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.
|Goal||Tier||Review Time||Performance Level|
FY 2008 – FY 2012 Submissions
|Issue a decision for 180-day PMA supplements||1||180 days||85% on time|
|2||210 days||95% on time|
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
|Type||FY 05||FY 06||FY 07||FY 08||FY 09|
|MDUFA Cohort Submissions||101||137||142||167*||167|
* FY 2008 number was updated to reflect a correction to the FY 2008 MDUFA Performance Report.
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.
|Fiscal Year||Cohort Closed||Received||Pending|
|Overdue||On Time||Percent |
|Issue a decision for 180-day PMA supplements||1||Issue 85% within |
|2||Issue 95% within |
Next page: Real-Time PMA Supplements