Main Approximately 8,800 mammography facilities are inspected annually by FDA-certified MQSA inspectors (comprised of both FDA inspectors and State inspectors). MQSA inspections ensure that quality standards are met. Inspection findings are graduated from Level 1, 2, 3 to “no observation,” which reflects the degree of the facility’s violation from most serious to fully compliant, respectively. A Level 1 finding represents a deviation from MQSA standards that may seriously compromise the quality of mammography services offered by the facility (i.e. sufficient objects in phantom image not visible). Gross adherence to MQSA standards is a valuable indicator of the efficacy of breast cancer diagnoses in the United States. <i>Information is current as of September 30, 2012</i> (1) Level 1 inspection observations are considered the most serious - those that may have a detrimental effect on the quality of mammography services. An example is a facility that has mammography personnel who do not meet FDA’s minimum qualification standards. Level 1 violation require FDA to issue a warning letter; the facility must begin correcting problems immediately and respond in writing to FDA within 15 work days of receiving the warning letter about the corrective actions taken. Percent column 0 100 Target

FY 2010 Overall: 99.07%

Oct 2009 98.80 Nov 2009 99.48 Dec 2009 98.62 Jan 2010 98.94 Feb 2010 99.10 Mar 2010 98.89 Apr 2010 99.09 May 2010 99.13 Jun 2010 99.03 Jul 2010 99.26 Aug 2010 99.26 Sep 2010 99.22 0 100 Target

FY 2011 Overall: 99.46%

Oct 2010 99.63 Nov 2010 99.25 Dec 2010 99.57 Jan 2011 99.63 Feb 2011 99.53 Mar 2011 99.65 Apr 2011 99.58 May 2011 99.45 Jun 2011 99.49 Jul 2011 98.94 Aug 2011 99.38 Sep 2011 99.44 0 100

FY 2012 Overall: 99.16%

Oct 2011 98.80 Nov 2011 98.97 Dec 2011 99.14 Jan 2012 99.33 Feb 2012 99.27 Mar 2012 99.10 Apr 2012 99.25 May 2012 99.17 Jun 2012 99.16 Jul 2012 99.26 Aug 2012 99.09 Sep 2012 99.33 Sub Percent of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the month (1) Number column 0 1000 Target

FY 2010 Total: 8,282

Oct 2009 741 Nov 2009 571 Dec 2009 644 Jan 2010 654 Feb 2010 551 Mar 2010 710 Apr 2010 765 May 2010 686 Jun 2010 718 Jul 2010 807 Aug 2010 675 Sep 2010 760 0 1000 Target

FY 2011 Total: 8,283

Oct 2010 536 Nov 2010 662 Dec 2010 692 Jan 2011 545 Feb 2011 632 Mar 2011 846 Apr 2011 705 May 2011 722 Jun 2011 782 Jul 2011 655 Aug 2011 800 Sep 2011 706 0 1000

FY 2012 Total: 8,284

Oct 2011 493 Nov 2011 675 Dec 2011 691 Jan 2012 594 Feb 2012 682 Mar 2012 768 Apr 2012 658 May 2012 717 Jun 2012 827 Jul 2012 674 Aug 2012 761 Sep 2012 744 Sub Percent of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the month (1) Number column 0 1000 Target

FY 2010 Total: 8,360

Oct 2009 750 Nov 2009 574 Dec 2009 653 Jan 2010 661 Feb 2010 556 Mar 2010 718 Apr 2010 772 May 2010 692 Jun 2010 725 Jul 2010 813 Aug 2010 680 Sep 2010 766 0 1000 Target

FY 2011 Total: 8,328

Oct 2010 538 Nov 2010 667 Dec 2010 695 Jan 2011 547 Feb 2011 635 Mar 2011 849 Apr 2011 708 May 2011 726 Jun 2011 786 Jul 2011 662 Aug 2011 805 Sep 2011 710 0 1000

FY 2012 Total: 8,354

Oct 2011 499 Nov 2011 682 Dec 2011 697 Jan 2012 598 Feb 2012 687 Mar 2012 775 Apr 2012 663 May 2012 723 Jun 2012 834 Jul 2012 679 Aug 2012 768 Sep 2012 749 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038 FDA-TRACK CDRH Dashboard http://www.fda.gov/radiation-emittingproducts/mammographyqualitystandardsactandprogram/default.htm Mammography Quality Standards Act and Program http://www.fda.gov/AboutFDA/Transparency/track/ucm203038 FDA-TRACK CDRH Dashboard ਍††਍਍਍਍਍਍਍