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US FDA Proposes Biggest Mammography Rule Change In 20 Years

US FDA wants to make significant changes to how mammographers interact with patients in terms of the information they share about the procedure and standards they will have to follow. The issue specifically addresses scenarios where patients with denser breast tissue may not be fully informed about the accuracy of their mammography tests. If the agency's proposal moves forward, it will be the biggest regulatory change for the mammography industry in more than two decades.

Close up of Doctor reviewing mammography results on x-ray and typing results on laptop. - Image

US FDA on March 27 proposed a major change to mammography regulations that would require mammographers to give patients more information on the limitations of mammography tests, especially for patients with denser breast tissue. They would also need to adhere to new mammography standards.

“For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve the quality of mammography services for millions of Americans,” FDA said in a statement announcing the proposed rule changes. “Today's actions would expand the information mammography facilities must provide to patients and health-care professionals, allowing for more informed medical decision-making

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