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U.S. Department of Health and Human Services

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, 2013

Fiscal Year - 2011

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Cumulative FY 2011 Target: 1,175 by 9/30/2011

TimeCumulative Annual TargetCumulative Number
Oct 20101,175142
Nov 20101,175304
Dec 20101,175418
Jan 20111,175555
Feb 20111,175686
Mar 20111,175853
Apr 20111,175978
May 20111,1751,114
Jun 20111,1751,272
Jul 20111,1751,400
Aug 20111,1751,569
Sep 20111,1751,719

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
Skip graphic and jump to text data.

Cumulative FY 2011 Target: 1,175 by 9/30/2011

TimeTargetNumber
Oct 2010N/A142
Nov 2010N/A162
Dec 2010N/A114
Jan 2011N/A137
Feb 2011N/A131
Mar 2011N/A167
Apr 2011N/A125
May 2011N/A136
Jun 2011N/A158
Jul 2011N/A128
Aug 2011N/A169
Sep 2011N/A150

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.