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

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.

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 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. Additionally, dense breasts have been identified as a risk factor for developing breast cancer. The amendments finalized today provide specific language explaining how breast density can influence the accuracy of mammography. They recommend patients with dense breasts talk to their health care providers about breast density, risks for breast cancer, and their individual situations.

According to the Centers for Disease Control and Prevention, about one in eight women will get breast cancer in her life, impacting hundreds of thousands of Americans each year.