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U.S. Department of Health and Human Services

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Quarterly Performance Reports

FY 2009 MDUFA Performance Report Table of Contents

During FY 2009, FDA reported its quarterly progress toward meeting the quantitative MDUFA II goals. The latest quarterly performance report is typically posted in the month following the close of each quarter and is available at: MDUFMA Reports.


Total Review Times to Final Decisions

The table below presents the total median review time required to render an FDA final decision for approval, denial, SE, and NSE, measured in elapsed days from receipt (or filing, for applications subject to filing) to FDA’s final decision. This measure, which includes both FDA and industry time, provides an indication of how well FDA and industry are doing in their mutual efforts to ensure that reasonably safe and effective medical devices reach patients and healthcare professionals in a timely manner. FDA will update this data for each cohort in subsequent reports until each cohort is complete (meaning there is an FDA final decision, or an applicant withdrawal, for each application in the cohort).
 

Application TypeFY 2008FY 2009FY 2010FY 2011FY 2012
PMAs, Panel-track PMA Supplements, and Premarket ReportsNumber of Final Decisions143------
Median Time to Decisions (Days)180*174*------
Expedited PMAs and Panel-track PMA SupplementsNumber of Final Decisions10------
Median Time to Decisions (Days)177*n/a------
180-day PMA SupplementsNumber of Final Decisions13474------
Median Time to Decisions (Days)153*132*------
Real-Time PMA SupplementsNumber of Final Decisions237232------
Median Time to Decisions (Days)46*55*------
510(k) Premarket NotificationsNumber of Final Decisions3,2612,139------
Median Time to Decisions (Days)88*80*------

*Estimate as cohort is still open for review.

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