Main The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. This program is critical for identifying side effects that were not identifiable during the premarket testing phase. This measure evaluates CDRH’s timeliness in issuing decision letters for various stages of the post-approval commitments, including post-approval protocols and reviews of interim and final study reports. <i>Information is current as of December 31, 2012</i> Percent line 0 100 Target

FY 2010 Overall: 93%

Oct 2009 90 83 Nov 2009 90 90 Dec 2009 90 89 Jan 2010 90 89 Feb 2010 90 98 Mar 2010 90 94 Apr 2010 90 92 May 2010 90 93 Jun 2010 90 100 Jul 2010 90 95 Aug 2010 90 100 Sep 2010 90 98 0 100 Target

FY 2011 Overall: 98%

Oct 2010 90 100 Nov 2010 90 97 Dec 2010 90 100 Jan 2011 90 100 Feb 2011 90 95 Mar 2011 90 100 Apr 2011 90 98 May 2011 90 96 Jun 2011 90 98 Jul 2011 90 96 Aug 2011 90 100 Sep 2011 90 98 0 100

FY 2012 Overall: 96%

Oct 2011 90 96 Nov 2011 90 98 Dec 2011 90 96 Jan 2012 90 96 Feb 2012 90 95 Mar 2012 90 100 Apr 2012 90 98 May 2012 90 96 Jun 2012 90 91 Jul 2012 90 100 Aug 2012 90 98 Sep 2012 90 89 0 100

FY 2013 YTD: 94%

Oct 2012 90 98 Nov 2012 90 93 Dec 2012 90 91 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Percent of Post-Approval Study (PAS) decision letters completed within established time frames during the month Number column 0 75 Target

FY 2010 Total: 519

Oct 2009 38 Nov 2009 43 Dec 2009 55 Jan 2010 42 Feb 2010 43 Mar 2010 50 Apr 2010 44 May 2010 27 Jun 2010 45 Jul 2010 54 Aug 2010 32 Sep 2010 46 0 75 Target

FY 2011 Total: 521

Oct 2010 41 Nov 2010 32 Dec 2010 45 Jan 2011 38 Feb 2011 41 Mar 2011 40 Apr 2011 50 May 2011 55 Jun 2011 50 Jul 2011 43 Aug 2011 35 Sep 2011 51 0 75

FY 2012 Total: 613

Oct 2011 47 Nov 2011 51 Dec 2011 53 Jan 2012 49 Feb 2012 55 Mar 2012 50 Apr 2012 48 May 2012 54 Jun 2012 60 Jul 2012 49 Aug 2012 64 Sep 2012 33

FY 2013 YTD: 146

Oct 2012 48 Nov 2012 50 Dec 2012 48 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Percent of Post-Approval Study (PAS) decision letters completed within established time frames during the month Number column 0 75 Target

FY 2010 Total: 558

Oct 2009 46 Nov 2009 48 Dec 2009 62 Jan 2010 47 Feb 2010 44 Mar 2010 53 Apr 2010 48 May 2010 29 Jun 2010 45 Jul 2010 57 Aug 2010 32 Sep 2010 47 0 75 Target

FY 2011 Total: 531

Oct 2010 41 Nov 2010 33 Dec 2010 45 Jan 2011 38 Feb 2011 43 Mar 2011 40 Apr 2011 51 May 2011 57 Jun 2011 51 Jul 2011 45 Aug 2011 35 Sep 2011 52 0 75

FY 2012 Total: 637

Oct 2011 49 Nov 2011 52 Dec 2011 55 Jan 2012 51 Feb 2012 58 Mar 2012 50 Apr 2012 49 May 2012 56 Jun 2012 66 Jul 2012 49 Aug 2012 65 Sep 2012 37

FY 2013 YTD: 156

Oct 2012 49 Nov 2012 54 Dec 2012 53 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard ਍††਍਍਍਍਍਍਍