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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 - 2011

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TimeTargetPercent
Oct 20108591
Nov 20108597
Dec 201085100
Jan 201185100
Feb 20118580
Mar 20118595
Apr 20118596
May 201185100
Jun 201185100
Jul 20118583
Aug 20118588
Sep 20118597

FY 2011 Overall: 94%

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A10
Nov 2010N/A34
Dec 2010N/A12
Jan 2011N/A15
Feb 2011N/A12
Mar 2011N/A20
Apr 2011N/A27
May 2011N/A21
Jun 2011N/A29
Jul 2011N/A19
Aug 2011N/A21
Sep 2011N/A33

FY 2011 Total: 253

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A11
Nov 2010N/A35
Dec 2010N/A12
Jan 2011N/A15
Feb 2011N/A15
Mar 2011N/A21
Apr 2011N/A28
May 2011N/A21
Jun 2011N/A29
Jul 2011N/A23
Aug 2011N/A24
Sep 2011N/A34

FY 2011 Total: 268

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.