About FDA
Cumulative number of technical reviews of new applications and data supporting requests for premarket approvals completed
Cumulative FY 2011 Target: 1,175 by 9/30/2011
Dictionary: Laboratory staff conduct technical reviews for new applications having the most novel, difficult, and complex engineering analyses and issues. The most challenging premarket device regulatory issues faced by CDRH typically involve (1) novel technologies in which the relevant technical questions are not obvious; (2) submissions in which there is a need for independent data to verify manufacturers’ claims; or (3) new products for which there are no well validated test methods. Technical reviews by OSEL engineers and scientists bring specialized expertise to the process, frequently enabling CDRH to address these challenges with a science-based decision process.
Information is current as of September 30, 2012
Fiscal Year - 2011
Cumulative FY 2011 Target: 1,175 by 9/30/2011
| Time | Cumulative Annual Target | Cumulative Number |
|---|---|---|
| Oct 2010 | 1,175 | 142 |
| Nov 2010 | 1,175 | 304 |
| Dec 2010 | 1,175 | 418 |
| Jan 2011 | 1,175 | 555 |
| Feb 2011 | 1,175 | 686 |
| Mar 2011 | 1,175 | 853 |
| Apr 2011 | 1,175 | 978 |
| May 2011 | 1,175 | 1,114 |
| Jun 2011 | 1,175 | 1,272 |
| Jul 2011 | 1,175 | 1,400 |
| Aug 2011 | 1,175 | 1,569 |
| Sep 2011 | 1,175 | 1,719 |
FY 2011 Total: 1,719
Number of technical reviews of new applications and data supporting requests for premarket approvals completed during the month
Cumulative FY 2011 Target: 1,175 by 9/30/2011
Fiscal Year - 2011
Cumulative FY 2011 Target: 1,175 by 9/30/2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 142 |
| Nov 2010 | N/A | 162 |
| Dec 2010 | N/A | 114 |
| Jan 2011 | N/A | 137 |
| Feb 2011 | N/A | 131 |
| Mar 2011 | N/A | 167 |
| Apr 2011 | N/A | 125 |
| May 2011 | N/A | 136 |
| Jun 2011 | N/A | 158 |
| Jul 2011 | N/A | 128 |
| Aug 2011 | N/A | 169 |
| Sep 2011 | N/A | 150 |
FY 2011 Total: 1,719
Glossary
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
