About FDA

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

• FY 2010
• FY 2011
• FY 2012
• All

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	12
Nov 2011	N/A	39
Dec 2011	N/A	17
Jan 2012	N/A	11
Feb 2012	N/A	17
Mar 2012	N/A	13
Apr 2012	N/A	35
May 2012	N/A	11
Jun 2012	N/A	11
Jul 2012	N/A	7
Aug 2012	N/A	17
Sep 2012	N/A	24

FY 2012 Total: 214

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	15
Nov 2011	N/A	40
Dec 2011	N/A	17
Jan 2012	N/A	12
Feb 2012	N/A	17
Mar 2012	N/A	14
Apr 2012	N/A	37
May 2012	N/A	13
Jun 2012	N/A	11
Jul 2012	N/A	7
Aug 2012	N/A	26
Sep 2012	N/A	24

FY 2012 Total: 233