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Cumulative number of technical reviews of new applications and data supporting requests for premarket approvals completed
Cumulative FY 2013 Target: 1,300 by 9/30/2013
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 - 2013
Cumulative FY 2013 Target: 1,300 by 9/30/2013
| Time | Cumulative Annual Target | Cumulative Number |
|---|---|---|
| Oct 2012 | 1300 | 128 |
| Nov 2012 | 1300 | 260 |
| Dec 2012 | 1300 | 382 |
| Jan 2013 | 1300 | TBD |
| Feb 2013 | 1300 | TBD |
| Mar 2013 | 1300 | TBD |
| Apr 2013 | 1300 | TBD |
| May 2013 | 1300 | TBD |
| Jun 2013 | 1300 | TBD |
| Jul 2013 | 1300 | TBD |
| Aug 2013 | 1300 | TBD |
| Sep 2013 | 1300 | TBD |
FY 2013 YTD: 382
Number of technical reviews of new applications and data supporting requests for premarket approvals completed during the month
Fiscal Year - 2013
| Time | Target | Number |
|---|---|---|
| Oct 2012 | N/A | 128 |
| Nov 2012 | N/A | 132 |
| Dec 2012 | N/A | 122 |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 382
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.
