Breast Density.—The Committee recognizes the importance of patients receiving their own personal medical information and directs the Food and Drug Administration to ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density specified by the Secretary, including, at a minimum, the effect of breast density in masking the presence of breast cancer on a mammogram, the qualitative assessment of the provider who interpreted the mammogram, and a reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.
Please read the complete document: FDA MSQA Release 2023
New dense breast legislation to be implemented September 2024