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March 9, 1994

Interim Federal Quality Standards for Nation's Mammography Facilities Acquire Force of Law

JAMA. 1994;271(10):735-736. doi:10.1001/jama.1994.03510340021009

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ALL MAMMOGRAPHY facilities in the United States have until October 1 to meet new federal quality standards and be certified by the US Food and Drug Administration (FDA) in order to stay in business.

The FDA's interim regulations on quality standards and certification requirements were distributed to the nation's mammography facilities and published in the December 21, 1993, Federal Register. On February 22, after a 30-day comment period, the regulations acquired the force of law, says Florence Houn, MD, MPH, program manager of the FDA's Division of Mammography Quality and Radiation Programs, Rockville, Md. This newly created division is responsible for implementing the accreditation and certification program mandated by the federal Mammography Quality Standards Act (MQSA) of 1992.

The FDA will study the comments and suggestions received before drawing up final regulations, which should be published by the end of 1995, Houn says.

The new regulations are an important first

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