FDA issues breast density reporting mandate, but supplemental screening still out of reach for many

DOTmed March 14, 2023
John R. Fischer

Over a decade after agreeing that women should be informed about breast density, the FDA has enacted regulatory updates that will require mammography facilities to do just this.

Published on March 9, the amendments to the Mammography Quality Standards Act (MQSA) require these sites to include breast density information in reports following mammograms, including how density affects exam accuracy.

They create a “minimum” reporting standard that calls for specific language to explain the effects of breast density, as well as recommendations for patients to consult with their providers about their own breast density and risks for breast cancer, says the FDA.

Approximately half of women over 40 in the U.S. have dense breast tissue, which can obscure tumors on mammograms...

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