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U.S. Department of Health and Human Services

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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, 2013

Fiscal Year - 2013

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Cumulative FY 2013 Target: 1,300 by 9/30/2013

TimeCumulative Annual TargetCumulative Number
Oct 20121300128
Nov 20121300260
Dec 20121300382
Jan 20131300528
Feb 20131300642
Mar 20131300782
Apr 20131300964
May 201313001,119
Jun 201313001,273
Jul 201313001,459
Aug 201313001,618
Sep 20131300TBD

FY 2013 Cumulative Total: 1,618

Number of technical reviews of new applications and data supporting requests for premarket approvals completed during the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A128
Nov 2012N/A132
Dec 2012N/A122
Jan 2013N/A146
Feb 2013N/A114
Mar 2013N/A140
Apr 2013N/A182
May 2013N/A155
Jun 2013N/A154
Jul 2013N/A186
Aug 2013N/A159
Sep 2013N/ATBD

FY 2013 YTD: 1,928

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.