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U.S. Department of Health and Human Services

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Percentage of times a decision is issued for a 510(k) within 90 days

Dictionary: A 510(k) is a premarket notification made to FDA which contains information that demonstrates that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to Premarket Approval (PMA). This measure will allow OBRR to determine its performance in issuing decisions within established timeframes.

Information is current as of September 30, 2012

Fiscal Year - 2010

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TimeTargetPercent
Oct 200990100
Nov 200990100
Dec 200990100
Jan 201090100
Feb 201090100
Mar 201090100
Apr 201090100
May 201090100
Jun 201090100
Jul 201090100
Aug 20109083
Sep 201090100

FY 2010 Overall: 98%

Number of 510(k) premarket notifications with final action issued during the month, for which final action was issued within the statutory 90 day FDA review time

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A2
Nov 2009N/A4
Dec 2009N/A3
Jan 2010N/A5
Feb 2010N/A3
Mar 2010N/A2
Apr 2010N/A3
May 2010N/A4
Jun 2010N/A6
Jul 2010N/A7
Aug 2010N/A5
Sep 2010N/A1

FY 2010 Total: 45

Number of 510(k) premarket notifications with final action issued during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A2
Nov 2009N/A4
Dec 2009N/A3
Jan 2010N/A5
Feb 2010N/A3
Mar 2010N/A2
Apr 2010N/A3
May 2010N/A4
Jun 2010N/A6
Jul 2010N/A7
Aug 2010N/A6
Sep 2010N/A1

FY 2010 Total: 46

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.