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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 2012 Target: 1,300 by 9/30/2012

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 - 2012

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Cumulative FY 2012 Target: 1,300 by 9/30/2012

TimeCumulative Annual TargetCumulative Number
Oct 20111,300157
Nov 20111,300303
Dec 20111,300440
Jan 20121,300565
Feb 20121,300717
Mar 20121,300866
Apr 20121,3001,044
May 20121,3001,201
Jun 20121,3001,363
Jul 20121,3001,547
Aug 20121,3001,773
Sep 20121,3001,928

FY 2012 Cumulative Total: 1,928

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

Cumulative FY 2012 Target: 1,300 by 9/30/2012

Fiscal Year - 2012
Skip graphic and jump to text data.

Cumulative FY 2012 Target: 1,300 by 9/30/2012

TimeTargetNumber
Oct 2011N/A157
Nov 2011N/A146
Dec 2011N/A137
Jan 2012N/A125
Feb 2012N/A152
Mar 2012N/A149
Apr 2012N/A178
May 2012N/A157
Jun 2012N/A162
Jul 2012N/A184
Aug 2012N/A226
Sep 2012N/A155

FY 2012 Total: 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.