Main CDRH uses the internal expert consultation process to acquire information and analysis on issues related to medical devices. Intra- and inter-office consultations are completed for a variety of work products requiring expertise within and across CDRH offices, including premarket device submissions, post-approval studies, and compliance and enforcement actions. Inter-office eConsults are used to facilitate the exchange of scientific information and staff expertise across CDRH, critical to making well-supported regulatory decisions. eConsult is the system CDRH uses to manage and monitor expert consult requests. <i>Information is current as of December 31, 2012</i> Percent line 0 100 Target

FY 2011 Overall: 88%

Oct 2010 85 88 Nov 2010 85 87 Dec 2010 85 88 Jan 2011 85 87 Feb 2011 85 88 Mar 2011 85 89 Apr 2011 85 91 May 2011 85 88 Jun 2011 85 89 Jul 2011 85 88 Aug 2011 85 88 Sep 2011 85 88 0 100

FY 2012 Overall: 90%

Oct 2011 85 87 Nov 2011 85 89 Dec 2011 85 88 Jan 2012 85 91 Feb 2012 85 88 Mar 2012 85 90 Apr 2012 85 88 May 2012 85 91 Jun 2012 85 90 Jul 2012 85 91 Aug 2012 85 91 Sep 2012 85 89 0 100

FY 2013 YTD: 88%

Oct 2012 85 88 Nov 2012 85 88 Dec 2012 85 88 Jan 2013 85 Feb 2013 85 Mar 2013 85 Apr 2013 85 May 2012 85 Jun 2013 85 Jul 2013 85 Aug 2013 85 Sep 2013 85 Sub Percent of CDRH intra- and inter-Office eConsults completed on time during the month Number column 0 3000 Target

FY 2011 Total: 17,795

Oct 2010 1,276 Nov 2010 1,380 Dec 2010 1,283 Jan 2011 1,374 Feb 2011 1,282 Mar 2011 1,774 Apr 2011 1,545 May 2011 1,575 Jun 2011 1,820 Jul 2011 1,395 Aug 2011 1,646 Sep 2011 1,445 0 3000

FY 2012 Total: 19,956

Oct 2011 1,401 Nov 2011 1,517 Dec 2011 1,424 Jan 2012 1,515 Feb 2012 1,656 Mar 2012 1,924 Apr 2012 1,673 May 2012 1,746 Jun 2012 1,772 Jul 2012 1,820 Aug 2012 2,053 Sep 2012 1,455

FY 2013 YTD: 4,517

Oct 2012 1,602 Nov 2012 1,546 Dec 2012 1,369 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2012 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Percent of CDRH intra- and inter-Office eConsults completed on time during the month Number column 0 3000 Target

FY 2011 Total: 20,173

Oct 2010 1,452 Nov 2010 1,584 Dec 2010 1,463 Jan 2011 1,576 Feb 2011 1,460 Mar 2011 2,004 Apr 2011 1,704 May 2011 1,790 Jun 2011 2,049 Jul 2011 1,582 Aug 2011 1,860 Sep 2011 1,649 0 3000

FY 2012 Total: 22,295

Oct 2011 1,602 Nov 2011 1,712 Dec 2011 1,622 Jan 2012 1,656 Feb 2012 1,892 Mar 2012 2,144 Apr 2012 1,893 May 2012 1,909 Jun 2012 1,964 Jul 2012 1,994 Aug 2012 2,265 Sep 2012 1,642

FY 2013 YTD: 5,119

Oct 2012 1,820 Nov 2012 1,752 Dec 2012 1,547 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2012 Jun 2013 Jul 2013 Aug 2013 Sep 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard track?program=cdrh&id=CDRH-OCER-Percent-intra-and-inter-office-eConsults-on-time Percent of Office of Communication, Education, and Radiation Programs (OCER) intra- and inter-Office eConsults completed on time during the month track?program=cdrh&id=CDRH-OC-Percent-intra-and-inter-office-eConsults-on-time Percent of Office of Compliance (OC) intra- and inter-Office eConsults completed on time during the month track?program=cdrh&id=CDRH-ODE-Percent-intra-and-inter-office-eConsults-on-time Percent of Office of Device Evaluation (ODE) intra- and inter-Office eConsults completed on time during the month track?program=cdrh&id=CDRH-OIVD-Percent-intra-and-inter-office-eConsults-on-time Percent of Office of In Vitro Diagnostics Evaluation & Safety (OIVD) intra- and inter-Office eConsults completed on time during the month track?program=cdrh&id=CDRH-OSEL-Percent-intra-and-inter-office-eConsults-on-time Percent of Office of Science and Engineering Laboratories (OSEL) intra- and inter-Office eConsults completed on time during the month track?program=cdrh&id=CDRH-OSB-Percent-intra-and-inter-office-eConsults-on-time Percent of Office of Surveillance and Biometrics (OSB) intra- and inter-Office eConsults completed on time during the month ਍††਍਍਍਍਍਍਍