The U.S. Food and Drug Administration (FDA) updated its mammography regulations in March 2023 to require institutions to notify patients about their breast density. The updated regulations strengthen FDA’s oversight and enforcement of institutions and help healthcare providers better categorize and assess mammograms.
One of the regulations' key updates provides specific language for facilities to use to explain how breast density can influence the accuracy of patients’ mammography findings and recommend that patients with dense breasts talk to their healthcare provider about their density-related risks for breast cancer.
In its announcement about the updates, FDA said that they strengthen the agency’s oversight of mammography institutions and elevate its ability to communicate directly with patients and their healthcare providers in instances where a facility did not meet quality standards nor adequately communicate important information to patients.
FDA added that the updated regulations incorporate the latest evidence and mammography best practices to improve breast cancer detection and empower patients with more information when making decisions on care.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect, and treat cancer,” Hilary Marston, MD, MPH, FDA chief medical officer, said. “Since 1992, 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.”