FDA Brief: Update on Mammography Regulations

By: Lauren Velentzas
Posted: Friday, March 17, 2023

On March 9, the U.S. Food and Drug Administration (FDA) published updates to its mammography regulations, including—among other issues—a requirement for mammography facilities to notify patients about the density of their breasts to strengthen the FDA’s oversight and enforcement and to help interpreting physicians better categorize and assess mammograms. This update amends regulations under the Mammography Quality Standards Act (MQSA) of 1992. The MQSA helps to ensure quality mammography and assists with early breast cancer detection by authorizing FDA oversight over mammography facilities, including their accreditation, certification, annual inspections, and enforcement of standards.

The requirement of facilities to provide information to patients regarding the density of their breasts may help with the future detection of breast cancer, since dense breast tissue has been identified as a risk factor for developing the disease. The finalized amendment recommends that patients with dense breasts talk to their health-care providers about the associated risks.

The amendment will be required to be implemented within the next 18 months. It will enhance the FDA’s abilities to enforce these changes and communicate directly with patients and their health-care providers in cases where a facility did not meet quality standards.

U.S. Food and Drug Administration

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