Main A 510(k) is a premarket notification made to FDA which contains information that demonstrates 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 Premarket Approval (PMA). This measure will allow OBRR to determine its performance in issuing decisions within established timeframes. <i>Information is current as of September 30, 2012</i> Percent 0 100

FY 2010 Overall: 98%

Oct 2009 90 100 Nov 2009 90 100 Dec 2009 90 100 Jan 2010 90 100 Feb 2010 90 100 Mar 2010 90 100 Apr 2010 90 100 May 2010 90 100 Jun 2010 90 100 Jul 2010 90 100 Aug 2010 90 83 Sep 2010 90 100 0 100

FY 2011 Overall: 100%

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

FY 2012 Overall: 100%

Oct 2011 90 100 Nov 2011 90 100 Dec 2011 90 100 Jan 2012 90 100 Feb 2012 90 100 Mar 2012 90 100 Apr 2012 90 100 May 2012 90 100 Jun 2012 90 100 Jul 2012 90 100 Aug 2012 90 100 Sep 2012 90 100 Sub Percentage of times a decision is issued for a 510(k) within 90 days Number column

FY 2010 Total: 45

Oct 2009 2 Nov 2009 4 Dec 2009 3 Jan 2010 5 Feb 2010 3 Mar 2010 2 Apr 2010 3 May 2010 4 Jun 2010 6 Jul 2010 7 Aug 2010 5 Sep 2010 1

FY 2011 Total: 27

Oct 2010 4 Nov 2010 4 Dec 2010 3 Jan 2011 0 Feb 2011 1 Mar 2011 2 Apr 2011 3 May 2011 1 Jun 2011 3 Jul 2011 1 Aug 2011 3 Sep 2011 2

FY 2012 Total: 35

Oct 2011 2 Nov 2011 2 Dec 2011 4 Jan 2012 2 Feb 2012 3 Mar 2012 4 Apr 2012 1 May 2012 3 Jun 2012 5 Jul 2012 2 Aug 2012 3 Sep 2012 4 Sub Percentage of times a decision is issued for a 510(k) within 90 days Number column

FY 2010 Total: 46

Oct 2009 2 Nov 2009 4 Dec 2009 3 Jan 2010 5 Feb 2010 3 Mar 2010 2 Apr 2010 3 May 2010 4 Jun 2010 6 Jul 2010 7 Aug 2010 6 Sep 2010 1

FY 2011 Total: 27

Oct 2010 4 Nov 2010 4 Dec 2010 3 Jan 2011 0 Feb 2011 1 Mar 2011 2 Apr 2011 3 May 2011 1 Jun 2011 3 Jul 2011 1 Aug 2011 3 Sep 2011 2

FY 2012 Total: 35

Oct 2011 2 Nov 2011 2 Dec 2011 4 Jan 2012 2 Feb 2012 3 Mar 2012 4 Apr 2012 1 May 2012 3 Jun 2012 5 Jul 2012 2 Aug 2012 3 Sep 2012 4 http://www.fda.gov/AboutFDA/Transparency/track/ucm206804.htm FDA-TRACK CBER Dashboard word text word defintion ਍††਍਍਍਍਍਍਍