Main 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. <i>Information is current as of September 30, 2012</i> Percent line 0 100 Target

FY 2010 Overall: 99%

Oct 2009 95 100 Nov 2009 95 100 Dec 2009 95 100 Jan 2010 95 100 Feb 2010 95 92 Mar 2010 95 100 Apr 2010 95 98 May 2010 95 99 Jun 2010 95 100 Jul 2010 95 100 Aug 2010 95 100 Sep 2010 95 100 0 100 Target

FY 2011 Overall: 99%

Oct 2010 95 92 Nov 2010 95 100 Dec 2010 95 100 Jan 2011 95 100 Feb 2011 95 97 Mar 2011 95 100 Apr 2011 95 98 May 2011 95 99 Jun 2011 95 97 Jul 2011 95 100 Aug 2011 95 100 Sep 2011 95 100 0 100

FY 2012 Overall: 99%

Oct 2011 95 92 Nov 2011 95 100 Dec 2011 95 97 Jan 2012 95 100 Feb 2012 95 100 Mar 2012 95 98 Apr 2012 95 100 May 2012 95 100 Jun 2012 95 100 Jul 2012 95 99 Aug 2012 95 99 Sep 2012 95 100 Sub Percent of CDRH 30-Day Notices completed (found adequate and process change may be made) in 30 days or less during the month Number column 0 200 Target

FY 2010 Total: 1,074

Oct 2009 57 Nov 2009 63 Dec 2009 112 Jan 2010 85 Feb 2010 92 Mar 2010 94 Apr 2010 82 May 2010 79 Jun 2010 100 Jul 2010 93 Aug 2010 123 Sep 2010 94 0 200 Target

FY 2011 Total: 1,270

Oct 2010 66 Nov 2010 105 Dec 2010 112 Jan 2011 84 Feb 2011 61 Mar 2011 134 Apr 2011 65 May 2011 156 Jun 2011 118 Jul 2011 141 Aug 2011 145 Sep 2011 83 0 200

FY 2012 Total: 1,283

Oct 2011 106 Nov 2011 63 Dec 2011 107 Jan 2012 72 Feb 2012 87 Mar 2012 128 Apr 2012 128 May 2012 106 Jun 2012 99 Jul 2012 125 Aug 2012 131 Sep 2012 131 Sub Percent of CDRH 30-Day Notices completed (found adequate and process change may be made) in 30 days or less during the month Number column 0 200 Target

FY 2010 Total: 1,085

Oct 2009 57 Nov 2009 63 Dec 2009 112 Jan 2010 85 Feb 2010 100 Mar 2010 94 Apr 2010 84 May 2010 80 Jun 2010 100 Jul 2010 93 Aug 2010 123 Sep 2010 94 0 200 Target

FY 2011 Total: 1,285

Oct 2010 72 Nov 2010 105 Dec 2010 112 Jan 2011 84 Feb 2011 63 Mar 2011 134 Apr 2011 66 May 2011 158 Jun 2011 122 Jul 2011 141 Aug 2011 145 Sep 2011 83 0 200

FY 2012 Total: 1,300

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

FY 2010 Total: 179

Oct 2009 11 Nov 2009 16 Dec 2009 18 Jan 2010 16 Feb 2010 17 Mar 2010 16 Apr 2010 19 May 2010 21 Jun 2010 11 Jul 2010 16 Aug 2010 8 Sep 2010 10 Target

FY 2011 Total: 277

Oct 2010 27 Nov 2010 23 Dec 2010 17 Jan 2011 16 Feb 2011 4 Mar 2011 29 Apr 2011 44 May 2011 14 Jun 2011 28 Jul 2011 35 Aug 2011 18 Sep 2011 22

FY 2012 Total: 163

Oct 2011 0 Nov 2011 1 Dec 2011 34 Jan 2012 25 Feb 2012 15 Mar 2012 19 Apr 2012 21 May 2012 12 Jun 2012 9 Jul 2012 8 Aug 2012 15 Sep 2012 5 Main Number column Target

FY 2010 Total: 33

Oct 2009 0 Nov 2009 12 Dec 2009 2 Jan 2010 3 Feb 2010 2 Mar 2010 6 Apr 2010 2 May 2010 0 Jun 2010 1 Jul 2010 0 Aug 2010 3 Sep 2010 2 Target

FY 2011 Total: 48

Oct 2010 5 Nov 2010 3 Dec 2010 3 Jan 2011 6 Feb 2011 10 Mar 2011 4 Apr 2011 1 May 2011 2 Jun 2011 6 Jul 2011 1 Aug 2011 1 Sep 2011 6

FY 2012 Total: 45

Oct 2011 0 Nov 2011 2 Dec 2011 4 Jan 2012 4 Feb 2012 4 Mar 2012 10 Apr 2012 3 May 2012 3 Jun 2012 2 Jul 2012 8 Aug 2012 3 Sep 2012 3 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard ਍††਍਍਍਍਍਍਍