• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

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 - 2012

Skip graphic and jump to text data

TimeTargetPercent
Oct 20119592
Nov 201195100
Dec 20119597
Jan 201295100
Feb 201295100
Mar 20129598
Apr 201295100
May 201295100
Jun 201295100
Jul 20129599
Aug 20129599
Sep 201295100

FY 2012 Overall: 99%

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A106
Nov 2011N/A63
Dec 2011N/A107
Jan 2012N/A72
Feb 2012N/A87
Mar 2012N/A128
Apr 2012N/A128
May 2012N/A106
Jun 2012N/A99
Jul 2012N/A125
Aug 2012N/A131
Sep 2012N/A131

FY 2012 Total: 1,283

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A115
Nov 2011N/A63
Dec 2011N/A110
Jan 2012N/A72
Feb 2012N/A87
Mar 2012N/A131
Apr 2012N/A128
May 2012N/A106
Jun 2012N/A99
Jul 2012N/A126
Aug 2012N/A132
Sep 2012N/A131

FY 2012 Total: 1,300

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 - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A1
Dec 2011N/A34
Jan 2012N/A25
Feb 2012N/A15
Mar 2012N/A19
Apr 2012N/A21
May 2012N/A12
Jun 2012N/A9
Jul 2012N/A8
Aug 2012N/A15
Sep 2012N/A5

FY 2012 Total: 163

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

Fiscal Year - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A2
Dec 2011N/A4
Jan 2012N/A4
Feb 2012N/A4
Mar 2012N/A10
Apr 2012N/A3
May 2012N/A3
Jun 2012N/A2
Jul 2012N/A8
Aug 2012N/A3
Sep 2012N/A3

FY 2012 Total: 45

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.