New Mammography Rule Focuses on Breast Density and Facility Oversight

The FDA has released a final rule that updates the agency’s mammography regulations to address changes in technology and strengthen the FDA’s oversight of mammography facilities.

The final rule amends regulations issued under the Mammography Quality Standards Act (MQSA) of 1992, which authorized the FDA’s oversight of mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards.

Among other changes, the final rule requires mammography facilities to provide women with information on the density of their breast tissue, including specific language explaining how breast density can influence the accuracy of mammography and future risk of breast cancer, and a recommendation to consult with a healthcare provider over what the findings mean and any future steps.