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The regulation of mammography
1Department of Radiological Sciences, University of California, School of Medicine, Los Angeles 90095-6952, USA.
Abstract:
There has been a long history of public and professional concern about the safety and quality of mammography. Whereas concerns about radiation dose levels dominated the 1970s, the type of equipment used in mammography was the focus of the 1980s. In the early 1990s, there was a lack of confidence in the overall quality of mammography. These problems have stood in the way of the widespread utilization of mammography to reduce mortality from breast cancer. The Mammography Accreditation Program of the American College of Radiology, state regulations, and the Mammography Quality Standards Act of 1992 came about to ensure a minimum level of quality that would encourage women to participate in breast cancer screening programs. Designing regulations that ensure quality mammography for women, without burdening mammography facilities with unnecessary costs and depletion of their resources, is one of the most difficult challenges facing the U.S. Food and Drug Administration.