Bloomberg Law
March 9, 2023, 3:24 PM

FDA Updates Mammography Rules With Focus on Tissue Density

Bloomberg Law Automation
Bloomberg Law Automation

The Food and Drug Administration issued a final rule that amends regulations issued under the Mammography Quality Standards Act of 1992, the agency said Thursday.

The rule (RIN: 0910-AH04) will require facilities to notify patients about the density of their breasts and recommends patients with dense breasts talk to their health-care provider as it has been identified as a risk factor for developing breast cancer and can make cancers more difficult to detect on a mammogram, the FDA said.

The amendments are required to implemented within 18 months, according to the FDA.

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