The Food and Drug Administration today finalized a 2019 proposed rule updating requirements under the Mammography Quality Standards Act of 1992, which authorized FDA oversight of mammography facilities. Effective Sept. 10, 2024, the rule expands the information that mammography facilities must provide to patients and health care professionals, incorporates current best practices and enhances facility oversight, the FDA said. For example, the rule requires facilities to include information on breast density in the report to the clinician and the patient’s summary letter to enable patients and their doctors to have a more informed discussion about the enhanced risks associated with dense breasts if appropriate.

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