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U.S. Department of Health and Human Services

About FDA

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 - 2011

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TimeTargetPercent
Oct 201090100
Nov 201090100
Dec 201090100
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 201190100
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 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 - 2011
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TimeTargetNumber
Oct 2010N/A4
Nov 2010N/A4
Dec 2010N/A3
Jan 2011N/A0
Feb 2011N/A1
Mar 2011N/A2
Apr 2011N/A3
May 2011N/A1
Jun 2011N/A3
Jul 2011N/A1
Aug 2011N/A3
Sep 2011N/A2

FY 2011 Total: 27

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A4
Nov 2010N/A4
Dec 2010N/A3
Jan 2011N/A0
Feb 2011N/A1
Mar 2011N/A2
Apr 2011N/A3
May 2011N/A1
Jun 2011N/A3
Jul 2011N/A1
Aug 2011N/A3
Sep 2011N/A2

FY 2011 Total: 27

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.