Main The Office of Combination Products (OCP) is responsible for classifying products as either drugs, devices, biologics, or combination products and to assign the product to a Center for regulation. By submitting a RFD, a company may obtain a formal FDA determination of the status of their product. OCP must respond to a RFD within 60 days, or the requestor's recommended classification stands. A proper determination by OCP will enable the Agency to assign a particular product to the appropriate agency component for premarket review and postmarket regulation (CDER, CBER, or CDRH), and also enable the Agency to regulate the product under the proper regulatory authorities (NDA, 510(k), PMA, or BLA). <i>Information is current as of December 31, 2012.</i> Number of RFDs column

FY 2010 Total: 44

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

FY 2011 Total: 43

Oct 2010 5 Nov 2010 3 Dec 2010 1 Jan 2011 2 Feb 2011 6 Mar 2011 2 Apr 2011 3 May 2011 3 Jun 2011 8 Jul 2011 5 Aug 2011 3 Sep 2011 2

FY 2012 Total: 28

Oct 2011 2 Nov 2011 5 Dec 2011 3 Jan 2012 1 Feb 2012 4 Mar 2012 6 Apr 2012 3 May 2012 4 Jun 2012 3 Jul 2012 3 Aug 2012 0 Sep 2012 5

FY 2013 YTD: 7

Oct 2012 4 Nov 2012 1 Dec 2012 2 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/ucm206293.htm FDA-TRACK Office of Special Medical Programs Dashboard ਍††਍਍਍਍਍਍਍