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U.S. Department of Health and Human Services

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Percent of CDRH 30-Day Notices completed (found adequate and process change may be made) in 30 days or less during the month

Dictionary: Modifications to manufacturing procedures or methods of manufacturing that affect the safety and effectiveness of an approved Humanitarian Device Exemption (HDE) or Premarket Approval Application (PMA) do not require submission of a supplement and are eligible to be the subject of a 30-day notice. A 30-day notice describes, in detail, the change and summarizes the data or information supporting the change. The manufacturer may distribute the device 30 days after the date that FDA receives the 30-day notice, unless FDA notifies the applicant within 30 days from receipt of the notice that the notice is not adequate. If the notice is not adequate, FDA informs the applicant in writing that a 75-day HDE supplement or a 135-day PMA supplement is needed and describes further information or action required for acceptance of the change.

Information is current as of September 30, 2012

Fiscal Year - 2010

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TimeTargetPercent
Oct 200995100
Nov 200995100
Dec 200995100
Jan 201095100
Feb 20109592
Mar 201095100
Apr 20109598
May 20109599
Jun 201095100
Jul 201095100
Aug 201095100
Sep 201095100

FY 2010 Overall: 99%

Number of CDRH 30-Day Notices completed in 30 days or less during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A57
Nov 2009N/A63
Dec 2009N/A112
Jan 2010N/A85
Feb 2010N/A92
Mar 2010N/A94
Apr 2010N/A82
May 2010N/A79
Jun 2010N/A100
Jul 2010N/A93
Aug 2010N/A123
Sep 2010N/A94

FY 2010 Total: 1,074

Total number of CDRH 30-Day Notices completed during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A57
Nov 2009N/A63
Dec 2009N/A112
Jan 2010N/A85
Feb 2010N/A100
Mar 2010N/A94
Apr 2010N/A84
May 2010N/A80
Jun 2010N/A100
Jul 2010N/A93
Aug 2010N/A123
Sep 2010N/A94

FY 2010 Total: 1,085

Number of 30-Day Notices converted to 75/135-Day Supplements because (i) additional information or action was required, or (ii) a detailed review of the data supporting the change must be performed

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A11
Nov 2009N/A16
Dec 2009N/A18
Jan 2010N/A16
Feb 2010N/A17
Mar 2010N/A16
Apr 2010N/A19
May 2010N/A21
Jun 2010N/A11
Jul 2010N/A16
Aug 2010N/A8
Sep 2010N/A10

FY 2010 Total: 179

Number of 30-Day Notice submissions reviewed that “do not qualify as a 30-Day Notice” during the month

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A12
Dec 2009N/A2
Jan 2010N/A3
Feb 2010N/A2
Mar 2010N/A6
Apr 2010N/A2
May 2010N/A0
Jun 2010N/A1
Jul 2010N/A0
Aug 2010N/A3
Sep 2010N/A2

FY 2010 Total: 33

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.