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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 - 2011

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TimeTargetPercent
Oct 20109592
Nov 201095100
Dec 201095100
Jan 201195100
Feb 20119597
Mar 201195100
Apr 20119598
May 20119599
Jun 20119597
Jul 201195100
Aug 201195100
Sep 201195100

FY 2011 Overall: 99%

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A66
Nov 2010N/A105
Dec 2010N/A112
Jan 2011N/A84
Feb 2011N/A61
Mar 2011N/A134
Apr 2011N/A65
May 2011N/A156
Jun 2011N/A118
Jul 2011N/A141
Aug 2011N/A145
Sep 2011N/A83

FY 2011 Total: 1,270

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A72
Nov 2010N/A105
Dec 2010N/A112
Jan 2011N/A84
Feb 2011N/A63
Mar 2011N/A134
Apr 2011N/A66
May 2011N/A158
Jun 2011N/A122
Jul 2011N/A141
Aug 2011N/A145
Sep 2011N/A83

FY 2011 Total: 1,285

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 - 2011

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TimeTargetNumber
Oct 2010N/A27
Nov 2010N/A23
Dec 2010N/A17
Jan 2011N/A16
Feb 2011N/A4
Mar 2011N/A29
Apr 2011N/A44
May 2011N/A14
Jun 2011N/A28
Jul 2011N/A35
Aug 2011N/A18
Sep 2011N/A22

FY 2011 Total: 277

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

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A5
Nov 2010N/A3
Dec 2010N/A3
Jan 2011N/A6
Feb 2011N/A10
Mar 2011N/A4
Apr 2011N/A1
May 2011N/A2
Jun 2011N/A6
Jul 2011N/A1
Aug 2011N/A1
Sep 2011N/A6

FY 2011 Total: 48

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.