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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

• FY 2010
• FY 2011
• FY 2012
• All

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	106
Nov 2011	N/A	63
Dec 2011	N/A	107
Jan 2012	N/A	72
Feb 2012	N/A	87
Mar 2012	N/A	128
Apr 2012	N/A	128
May 2012	N/A	106
Jun 2012	N/A	99
Jul 2012	N/A	125
Aug 2012	N/A	131
Sep 2012	N/A	131

FY 2012 Total: 1,283

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	115
Nov 2011	N/A	63
Dec 2011	N/A	110
Jan 2012	N/A	72
Feb 2012	N/A	87
Mar 2012	N/A	131
Apr 2012	N/A	128
May 2012	N/A	106
Jun 2012	N/A	99
Jul 2012	N/A	126
Aug 2012	N/A	132
Sep 2012	N/A	131

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

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