Main All CDRH guidance documents require OCD clearance prior to publishing. Guidance documents are documents prepared for CDRH staff, regulated industry and the public that relate to (1) the processing, content, and evaluation of regulatory submissions, (2) the design, production, manufacturing, and testing of regulated products, and (3) the inspection and enforcement procedures. Guidance documents cleared by OCD assure that good guidance practice (GGP) policy has been fulfilled. Alternative approaches may be used pending they satisfy the requirements of the applicable statute, regulations, or both. A proposed list of guidance to be developed is posted every year for public comment, as required by the Medical Device User Fee Modernization Act (MDUFMA). <i>Information is current as of December 31, 2012</i> Cumulative Percent column 0 100 Adjusted Monthly Target Cumulative FY 2010 Target: 90% of 40 documents by 9/30/2010

FY 2010 Overall: 98%

Oct 2009 90 13 Nov 2009 90 18 Dec 2009 90 25 Jan 2010 90 25 Feb 2010 90 28 Mar 2010 90 33 Apr 2010 90 35 May 2010 90 40 Jun 2010 90 45 Jul 2010 90 55 Aug 2010 90 68 Sep 2010 90 98 0 Cumulative Annual Target Cumulative FY 2011 Target: 90% of 40 documents by 9/30/2011

FY 2011 Overall: 110%

Oct 2010 90 0 Nov 2010 90 8 Dec 2010 90 15 Jan 2011 90 15 Feb 2011 90 18 Mar 2011 90 40 Apr 2011 90 45 May 2011 90 70 Jun 2011 90 73 Jul 2011 90 88 Aug 2011 90 98 Sep 2011 90 110 0 Cumulative Annual Target Cumulative FY 2012 Target: 90% of 40 documents by 9/30/2012

FY 2012 Cumulative Total: 115%

Oct 2011 90 8 Nov 2011 90 20 Dec 2011 90 28 Jan 2012 90 33 Feb 2012 90 43 Mar 2012 90 50 Apr 2012 90 55 May 2012 90 65 Jun 2012 90 73 Jul 2012 90 78 Aug 2012 90 100 Sep 2012 90 115 Cumulative FY 2013 Target: 90% of 40 documents by 9/30/2013

FY 2013 YTD: 25%

Oct 2012 8 Nov 2012 10 Dec 2012 25 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2012 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Cumulative percent of guidance documents cleared by Office of the Center Director (OCD) Cumulative Number column 0 60 Target

FY 2010 Total: 39

Oct 2009 5 Nov 2009 7 Dec 2009 10 Jan 2010 10 Feb 2010 11 Mar 2010 13 Apr 2010 14 May 2010 16 Jun 2010 18 Jul 2010 22 Aug 2010 27 Sep 2010 39 0 60 Target

FY 2011 Total: 44

Oct 2010 0 Nov 2010 3 Dec 2010 6 Jan 2011 6 Feb 2011 7 Mar 2011 16 Apr 2011 18 May 2011 28 Jun 2011 29 Jul 2011 35 Aug 2011 39 Sep 2011 44 0 60

FY 2012 Total: 46

Oct 2011 3 Nov 2011 10 Dec 2011 12 Jan 2012 14 Feb 2012 16 Mar 2012 19 Apr 2012 21 May 2012 24 Jun 2012 29 Jul 2012 36 Aug 2012 40 Sep 2012 46

FY 2013 YTD: 9

Oct 2012 3 Nov 2012 4 Dec 2012 10 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2012 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Cumulative percent of guidance documents cleared by Office of the Center Director (OCD) Total Number column 0 60 Target

FY 2010 Total: 40

Oct 2009 40 Nov 2009 40 Dec 2009 40 Jan 2010 40 Feb 2010 40 Mar 2010 40 Apr 2010 40 May 2010 40 Jun 2010 40 Jul 2010 40 Aug 2010 40 Sep 2010 40 0 60 Target

FY 2011 Total: 40

Oct 2010 40 Nov 2010 40 Dec 2010 40 Jan 2011 40 Feb 2011 40 Mar 2011 40 Apr 2011 40 May 2011 40 Jun 2011 40 Jul 2011 40 Aug 2011 40 Sep 2011 40 0 60

FY 2012 Total: 40

Oct 2011 40 Nov 2011 40 Dec 2011 40 Jan 2012 40 Feb 2012 40 Mar 2012 40 Apr 2012 40 May 2012 40 Jun 2012 40 Jul 2012 40 Aug 2012 40 Sep 2012 40

FY 2013 YTD: 40

Oct 2012 40 Nov 2012 40 Dec 2012 40 Jan 2013 40 Feb 2013 40 Mar 2013 40 Apr 2013 40 May 2012 40 Jun 2013 40 Jul 2013 40 Aug 2013 40 Sep 2013 40 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038 FDA-TRACK CDRH Dashboard ਍††਍਍਍਍਍਍਍