FDA Proposes Updates to Mammography Facility Requirements

The Food and Drug Administration on March 28 published a proposed rule that would update requirements under the Mammography Quality Standards Act of 1992, which authorized FDA oversight of mammography facilities. The rule would expand the information that mammography facilities must provide to patients and health care professionals, modernize mammography quality standards and enhance facility oversight.

For example, the rule would require that the facility report 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. The agency will accept comments on the proposed rule for 90 days.