The US Food and Drug Administration (FDA), has announced important updates to mammography regulations, including new requirements for mammography facilities, strengthening FDA oversight and compliance of facilities, and helping interpreting physicians better classify and evaluate mammography mammograms.
The key update requires facilities to provide patients with information about the density of their breasts, which is important for early detection of breast cancer. Breast density can make cancers more difficult to detect on a mammogram, and dense breasts have also been identified as a risk factor for developing breast cancer. The finalized amendments provide specific language explaining how breast density can influence mammography accuracy.
Updated mammography regulations are important for the early detection of breast cancer, which affects hundreds of thousands of Americans each year. Mammograms remain the best tool for screening and detection of breast cancer.
These amendments, due to be implemented within 18 months, enhance FDA oversight of mammography facilities, including in the key areas of compliance and patient communication. In addition, the amendments help bring the MQSA into the 21st century, incorporating current mammography and scientific best practices to improve breast cancer detection and empower patients with more information when considering important decisions regarding breast care. health of your breasts.
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