About FDA
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 Type | FY 2008 | FY 2009 | FY 2010 | FY 2011 | FY 2012 | |
|---|---|---|---|---|---|---|
| PMAs, Panel-track PMA Supplements, and Premarket Reports | Number of Final Decisions | 14 | 3 | -- | -- | -- |
| Median Time to Decisions (Days) | 180* | 174* | -- | -- | -- | |
| Expedited PMAs and Panel-track PMA Supplements | Number of Final Decisions | 1 | 0 | -- | -- | -- |
| Median Time to Decisions (Days) | 177* | n/a | -- | -- | -- | |
| 180-day PMA Supplements | Number of Final Decisions | 134 | 74 | -- | -- | -- |
| Median Time to Decisions (Days) | 153* | 132* | -- | -- | -- | |
| Real-Time PMA Supplements | Number of Final Decisions | 237 | 232 | -- | -- | -- |
| Median Time to Decisions (Days) | 46* | 55* | -- | -- | -- | |
| 510(k) Premarket Notifications | Number of Final Decisions | 3,261 | 2,139 | -- | -- | -- |
| Median Time to Decisions (Days) | 88* | 80* | -- | -- | -- | |
*Estimate as cohort is still open for review.
Next page: Reviewer Training
