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U.S. Department of Health and Human Services

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Percent of CDRH 75/135-Day Supplement decisions made in 75/135 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 20098562
Nov 20098550
Dec 20098582
Jan 20108592
Feb 201085100
Mar 201085100
Apr 201085100
May 201085100
Jun 20108586
Jul 201085100
Aug 201085100
Sep 201085100

FY 2010 Overall: 85%

Number of CDRH 75/135-Day Supplement decisions made in 75/135 days or less during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A13
Nov 2009N/A14
Dec 2009N/A9
Jan 2010N/A12
Feb 2010N/A14
Mar 2010N/A15
Apr 2010N/A8
May 2010N/A10
Jun 2010N/A19
Jul 2010N/A8
Aug 2010N/A12
Sep 2010N/A22

FY 2010 Total: 156

Total number of CDRH 75/135-Day Supplement decisions made during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A21
Nov 2009N/A28
Dec 2009N/A11
Jan 2010N/A13
Feb 2010N/A14
Mar 2010N/A15
Apr 2010N/A8
May 2010N/A10
Jun 2010N/A22
Jul 2010N/A8
Aug 2010N/A12
Sep 2010N/A22

FY 2010 Total: 184

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.