FDA Releases Final Rule to Revise Mammography Quality Standards Act Regulations

The U.S. Food and Drug Administration (FDA) released a final rule updating the agency’s regulatory implementation of the Mammography Quality Standards Act Regulations of 1992 (MQSA). The American College of Radiology® (ACR®) is analyzing the final rule and will release further information for providers and accredited facilities once the review is complete.

The MQSA authorized the FDA to develop standards that would be enforced through strict accreditation, certification and inspection of equipment and personnel at mammography facilities. The ACR, via its Mammography Accreditation Program, is an FDA-approved accreditation body.

The FDA’s final rule makes several revisions to the program, including modifications related to repeated failure to achieve accreditation, breast density notification, record retention, equipment and quality control, and regulatory enforcement, among other issues. The rule goes into effect for mammography facilities Sept. 10, 2024.

Members with questions can contact Gloria Romanelli, JD, ACR Senior Director, Legislative and Regulatory Relations.