Mammography Quality Standards Act (MQSA) and the breast density notice

United States, the Mammography Quality Standards Act (42 U.S.C. 263b), implemented by FDA regulations in 21 CFR part 900, which set the standards a facility must meet to perform screening or diagnostic mammography and the system of accreditation bodies that check them.

Under 21 CFR 900.12(c), each mammography report must give an overall assessment of breast density in one of four categories, from "The breasts are almost entirely fatty" to "The breasts are extremely dense, which lowers the sensitivity of mammography". The facility must send the patient a lay summary within 30 calendar days. Where the tissue is heterogeneously or extremely dense, the summary must say: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation." Where it is not dense, a matching statement says so.