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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Mammography Quality Standards Act and Program

Photos of Mammography devices

October 2012 marks the 20th anniversary of the Mammography Quality Standards Act (MQSA). This legislation established national standards for accreditation, certification, and inspection of mammography facilities in the U.S. Because of these standards, millions of women who receive mammograms in the U.S. each year can be confident they are receiving high-quality, consistent and reliable breast imaging at mammography facilities across the country.

Through this legislation, FDA staff helped create an environment where nearly all mammography facilities operate according to national standards, free from major inspection violations. These standards have also helped optimize radiation doses, and ultimately contribute to improved detection, earlier treatment, and better outcomes for breast cancer patients.

FDA’s implementation of MQSA has encouraged health care providers and equipment manufacturers to improve quality and seek excellence while giving women the information they need to make better-informed health care decisions.

In 2012, twenty years after Congress passed MQSA, FDA's goal for the MQSA program remains, to improve the quality of the nation's mammography services. The Division of Mammography Quality Standards within CDRH continues to work toward that goal, keeping in mind an aim of affording quality mammography services for all of our nation's women with an efficient and least burdensome approach to facilities.



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