News | October 19, 2012

FDA Releases Mammography Quality Standards Act National Statistics

October 19, 2012 — The U.S. Food and Drug Administration (FDA) has reported information about national inspection results from its Mammography Quality Standards Act (MQSA) program.

The MQSA program is designed to inform the public on how mammography facilities are doing with regard to MQSA standards. It also allows facilities to compare themselves to the rest of the nation. Statistics include:

Certification statistics as of Sept. 1, 2012

  • Total certified facilities/Total accredited units: 8,639/12,456
  • Certified facilities with FFDM (full-field digital mammography) units/Accredited FFDM units: 7,447/10,887


FY 2012 inspection statistics as of Sept. 1, 2012

  • Facilities inspected: 7,605
  • Total units at inspected facilities: 10,612


Percent of inspections where the highest non-compliance was a

  • Level 1 violation: 0.8%
  • Level 2 violation: 13.1%
  • Level 3 violation: 2.5%


Percent of inspections with no violation: 83.7%

Total annual mammography procedures reported as of Sept. 1, 2012: 39,373,128*

* This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies. Facilities are asked to disclose this information at their initial accreditation, and then at the time of their re-accreditation, which takes place once every three years. FDA began collecting these data in 1998. The aggregate does not reflect the current number of procedures performed at these facilities, but only the numbers reported by them during the three-year period prior to the current date. We have aggregated only the numbers reported by certified, non-Veterans Administration facilities.

For more information: www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActand...

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