The amendments would update the regulations originally established under the Mammography Quality Standards Act (MQSA) of 1992. The new rule would recognize new breast imaging technologies, improve facility processes, and update reporting requirements, the agency said.
For example, the new rule would address breast density reporting to patients. The agency said it would consider different options for mammography regulation "so that the health benefits to patients are maximized and the economic burdens to mammography facilities are minimized."
"The FDA believes there are tremendous public health benefits to this rule, including the potential for earlier breast cancer detection, improved morbidity and mortality, resulting in reductions in cancer treatment costs, and allowing for more informed decision-making by strengthening the communication of healthcare information between patients and their providers," the agency said in a statement.
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