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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 - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290100
Feb 201290100
Mar 201290100
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 Overall: 100%

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 - 2012
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A2
Dec 2011N/A4
Jan 2012N/A2
Feb 2012N/A3
Mar 2012N/A4
Apr 2012N/A1
May 2012N/A3
Jun 2012N/A5
Jul 2012N/A2
Aug 2012N/A3
Sep 2012N/A4

FY 2012 Total: 35

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A2
Dec 2011N/A4
Jan 2012N/A2
Feb 2012N/A3
Mar 2012N/A4
Apr 2012N/A1
May 2012N/A3
Jun 2012N/A5
Jul 2012N/A2
Aug 2012N/A3
Sep 2012N/A4

FY 2012 Total: 35

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.