Main The Medical Device User Fee Amendments (MDUFA II) require FDA to pursue a comprehensive set of device review performance goals, intended to significantly improve the timeliness and predictability of FDA’s review of new devices. MDUFA II performance goals are measured by receipt cohort. By using the decision cohort, this measure provides a different approach to monitoring MDUFA related 510(k) performance goals. The measure tracks the number of 510(k) decisions made during the month that were within 90 FDA days. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to a Premarket Approval (PMA). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency (SE) claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. <i>Information is current as of December 31, 2012</i> Percent line 0 100 Target

FY 2010 Overall: 82%

Oct 2009 90 87 Nov 2009 90 93 Dec 2009 90 91 Jan 2010 90 69 Feb 2010 90 82 Mar 2010 90 81 Apr 2010 90 83 May 2010 90 83 Jun 2010 90 79 Jul 2010 90 82 Aug 2010 90 84 Sep 2010 90 72 0 100 Target

FY 2011 Overall: 85%

Oct 2010 85 79 Nov 2010 85 85 Dec 2010 85 80 Jan 2011 85 95 Feb 2011 85 87 Mar 2011 85 75 Apr 2011 85 88 May 2011 85 87 Jun 2011 85 85 Jul 2011 85 88 Aug 2011 85 88 Sep 2011 85 87 0 100

FY 2012 Overall: 91%

Oct 2011 90 88 Nov 2011 90 82 Dec 2011 90 88 Jan 2012 90 84 Feb 2012 90 96 Mar 2012 90 95 Apr 2012 90 90 May 2012 90 92 Jun 2012 90 100 Jul 2012 90 90 Aug 2012 90 89 Sep 2012 90 95 0 100

FY 2013 YTD: 96%

Oct 2012 90 100 Nov 2012 90 88 Dec 2012 90 97 Jan 2013 90 Feb 2013 90 Mar 2013 90 Apr 2013 90 May 2013 90 Jun 2013 90 Jul 2013 90 Aug 2013 90 Sep 2013 90 Sub Percent of Office of In Vitro Diagnostics and Radiological Health (OIR) 510(k) decisions meeting MDUFA goals during the month Number column 0 100 Target

FY 2010 Total: 434

Oct 2009 N/A 26 Nov 2009 N/A 27 Dec 2009 N/A 30 Jan 2010 N/A 11 Feb 2010 N/A 32 Mar 2010 N/A 62 Apr 2010 N/A 48 May 2010 N/A 34 Jun 2010 N/A 42 Jul 2010 N/A 41 Aug 2010 N/A 53 Sep 2010 N/A 28 0 100 Target

FY 2011 Total: 610

Oct 2010 N/A 56 Nov 2010 N/A 35 Dec 2010 N/A 40 Jan 2011 N/A 55 Feb 2011 N/A 46 Mar 2011 N/A 42 Apr 2011 N/A 60 May 2011 N/A 60 Jun 2011 N/A 41 Jul 2011 N/A 43 Aug 2011 N/A 58 Sep 2011 N/A 74 0 100

FY 2012 Total: 660

Oct 2011 50 Nov 2011 47 Dec 2011 70 Jan 2012 42 Feb 2012 44 Mar 2012 57 Apr 2012 57 May 2012 68 Jun 2012 55 Jul 2012 57 Aug 2012 59 Sep 2012 54

FY 2013 YTD: 152

Oct 2012 45 Nov 2012 38 Dec 2012 69 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Percent of Office of In Vitro Diagnostics and Radiological Health (OIR) 510(k) decisions meeting MDUFA goals during the month Number column 0 100 Target

FY 2010 Total: 528

Oct 2009 N/A 30 Nov 2009 N/A 29 Dec 2009 N/A 33 Jan 2010 N/A 16 Feb 2010 N/A 39 Mar 2010 N/A 77 Apr 2010 N/A 58 May 2010 N/A 41 Jun 2010 N/A 53 Jul 2010 N/A 50 Aug 2010 N/A 63 Sep 2010 N/A 39 0 100 Target

FY 2011 Total: 714

Oct 2010 N/A 71 Nov 2010 N/A 41 Dec 2010 N/A 50 Jan 2011 N/A 58 Feb 2011 N/A 53 Mar 2011 N/A 56 Apr 2011 N/A 68 May 2011 N/A 69 Jun 2011 N/A 48 Jul 2011 N/A 49 Aug 2011 N/A 66 Sep 2011 N/A 85 0 100

FY 2012 Total: 728

Oct 2011 57 Nov 2011 57 Dec 2011 80 Jan 2012 50 Feb 2012 46 Mar 2012 60 Apr 2012 63 May 2012 74 Jun 2012 55 Jul 2012 63 Aug 2012 66 Sep 2012 57

FY 2013 YTD: 159

Oct 2012 45 Nov 2012 43 Dec 2012 71 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 track?program=cdrh&id=CDRH-Premarket-Percent-510k-decisions-in-90-days Percent of CDRH (ODE & OIVD) 510(k) decisions in 90 days track?program=cdrh&id=CDRH-ODE-Percent-510k-decisions-in-90-days Percent of ODE 510(k) decisions in 90 days ਍††਍਍਍਍਍਍਍