Main Laboratory staff conduct technical reviews for new applications having the most novel, difficult, and complex engineering analyses and issues. The most challenging premarket device regulatory issues faced by CDRH typically involve (1) novel technologies in which the relevant technical questions are not obvious; (2) submissions in which there is a need for independent data to verify manufacturers’ claims; or (3) new products for which there are no well validated test methods. Technical reviews by OSEL engineers and scientists bring specialized expertise to the process, frequently enabling CDRH to address these challenges with a science-based decision process. <i>Information is current as of September 30, 2012</i> Cumulative Number column Cumulative Annual Target Cumulative FY 2010 Target: 1,175 by 9/30/2010

FY 2010 Total: 1,429

Oct 2009 1,175 88 Nov 2009 1,175 179 Dec 2009 1,175 268 Jan 2010 1,175 361 Feb 2010 1,175 454 Mar 2010 1,175 598 Apr 2010 1,175 713 May 2010 1,175 825 Jun 2010 1,175 993 Jul 2010 1,175 1,133 Aug 2010 1,175 1,317 Sep 2010 1,175 1,429 Cumulative Annual Target Cumulative FY 2011 Target: 1,175 by 9/30/2011

FY 2011 Total: 1,719

Oct 2010 1,175 142 Nov 2010 1,175 304 Dec 2010 1,175 418 Jan 2011 1,175 555 Feb 2011 1,175 686 Mar 2011 1,175 853 Apr 2011 1,175 978 May 2011 1,175 1,114 Jun 2011 1,175 1,272 Jul 2011 1,175 1,400 Aug 2011 1,175 1,569 Sep 2011 1,175 1,719 Cumulative Annual Target Cumulative FY 2012 Target: 1,300 by 9/30/2012

FY 2012 Cumulative Total: 1,928

Oct 2011 1,300 157 Nov 2011 1,300 303 Dec 2011 1,300 440 Jan 2012 1,300 565 Feb 2012 1,300 717 Mar 2012 1,300 866 Apr 2012 1,300 1,044 May 2012 1,300 1,201 Jun 2012 1,300 1,363 Jul 2012 1,300 1,547 Aug 2012 1,300 1,773 Sep 2012 1,300 1,928 Cumulative Annual Target Cumulative FY 2013 Target: 1,300 by 9/30/2013

FY 2013 YTD: 382

Oct 2012 1300 128 Nov 2012 1300 260 Dec 2012 1300 382 Jan 2013 1300 Feb 2013 1300 Mar 2013 1300 Apr 2013 1300 May 2013 1300 Jun 2013 1300 Jul 2013 1300 Aug 2013 1300 Sep 2013 1300 Main Number column Cumulative FY 2010 Target: 1,175 by 9/30/2010

FY 2010 Total: 1,429

Oct 2009 88 Nov 2009 91 Dec 2009 89 Jan 2010 93 Feb 2010 93 Mar 2010 144 Apr 2010 115 May 2010 112 Jun 2010 168 Jul 2010 140 Aug 2010 184 Sep 2010 112 Cumulative FY 2011 Target: 1,175 by 9/30/2011

FY 2011 Total: 1,719

Oct 2010 142 Nov 2010 162 Dec 2010 114 Jan 2011 137 Feb 2011 131 Mar 2011 167 Apr 2011 125 May 2011 136 Jun 2011 158 Jul 2011 128 Aug 2011 169 Sep 2011 150 Cumulative FY 2012 Target: 1,300 by 9/30/2012

FY 2012 Total: 1,928

Oct 2011 157 Nov 2011 146 Dec 2011 137 Jan 2012 125 Feb 2012 152 Mar 2012 149 Apr 2012 178 May 2012 157 Jun 2012 162 Jul 2012 184 Aug 2012 226 Sep 2012 155

FY 2013 YTD: 382

Oct 2012 128 Nov 2012 132 Dec 2012 122 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 ਍††਍਍਍਍਍਍਍