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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 2010 Target: 1,175 by 9/30/2010

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 - 2010

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Cumulative FY 2010 Target: 1,175 by 9/30/2010

TimeCumulative Annual TargetCumulative Number
Oct 20091,17588
Nov 20091,175179
Dec 20091,175268
Jan 20101,175361
Feb 20101,175454
Mar 20101,175598
Apr 20101,175713
May 20101,175825
Jun 20101,175993
Jul 20101,1751,133
Aug 20101,1751,317
Sep 20101,1751,429

FY 2010 Total: 1,429

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

Cumulative FY 2010 Target: 1,175 by 9/30/2010

Fiscal Year - 2010
Skip graphic and jump to text data.

Cumulative FY 2010 Target: 1,175 by 9/30/2010

TimeTargetNumber
Oct 2009N/A88
Nov 2009N/A91
Dec 2009N/A89
Jan 2010N/A93
Feb 2010N/A93
Mar 2010N/A144
Apr 2010N/A115
May 2010N/A112
Jun 2010N/A168
Jul 2010N/A140
Aug 2010N/A184
Sep 2010N/A112

FY 2010 Total: 1,429

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.