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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 - 2012

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TimeTargetPercent
Oct 20118580
Nov 20118598
Dec 201185100
Jan 20128592
Feb 201285100
Mar 20128593
Apr 20128595
May 20128585
Jun 201285100
Jul 201285100
Aug 20128565
Sep 201285100

FY 2012 Overall: 92%

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A12
Nov 2011N/A39
Dec 2011N/A17
Jan 2012N/A11
Feb 2012N/A17
Mar 2012N/A13
Apr 2012N/A35
May 2012N/A11
Jun 2012N/A11
Jul 2012N/A7
Aug 2012N/A17
Sep 2012N/A24

FY 2012 Total: 214

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A15
Nov 2011N/A40
Dec 2011N/A17
Jan 2012N/A12
Feb 2012N/A17
Mar 2012N/A14
Apr 2012N/A37
May 2012N/A13
Jun 2012N/A11
Jul 2012N/A7
Aug 2012N/A26
Sep 2012N/A24

FY 2012 Total: 233

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.