Regulatory Compliance in Mammography.

Although the Mammography Quality Standards Act (MQSA) passed when analog mammography and film processors were used across the United States, now most health care facilities have full-field digital mammography. This article reviews MQSA requirements including qualifications for personnel, the clinical image evaluation process, and components of a quality control program. In light of technological advances, the U.S. Food and Drug Administration's extension certificate for digital breast tomosynthesis is discussed, along with the American College of Radiology's Breast Imaging Center of Excellence designation and laws regarding density notification.