FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight

For Immediate Release: March 09, 2023

Today, the U.S. Food and Drug Administration published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, M.D., M.P.H., FDA’s Chief Medical Officer. “Since 1992, the FDA has worked to ensure patients have access to quality mammography. The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards. This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”

The final rule amends regulations issued under the Mammography Quality Standards Act (MQSA) of 1992, a law passed to ensure quality mammography, which is very important for early breast cancer detection. The MQSA authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections, and enforcement of standards to help ensure mammography facilities provide quality care.

One of the key updates to regulations under the MQSA requires facilities to provide information to patients regarding the density of their breasts. Approximately half of the women over the age of 40 in the U.S. have dense breast tissue, a description of its appearance on a mammogram. Dense breast tissue can make cancers more difficult to detect on a mammogram.
FDA Updates Mammography Regulations Require Reporting Breast Density Information and Enhance Facility Oversight