FDA Strengthens Mammography Regulations: Final Rule

11 Mar 2023 • The U.S. Food and Drug Administration (FDA) has updated mammography regulations to include requirements for mammography facilities to notify patients about the density of their breasts.

The new rule also strengthens the FDA’s oversight and enforcement of facilities and helps interpreting physicians better categorise and assess mammograms. The FDA Chief Medical Officer, Hilary Marston, said the rule represents the agency’s commitment to support innovation to prevent, detect and treat cancer.

The Mammography Quality Standards Act (MQSA) was passed in 1992 to ensure quality mammography for early breast cancer detection. One of the key updates is that facilities must provide information to patients regarding the density of their breasts. Dense breast tissue can make cancers more difficult to detect on a mammogram.

The amendments finalised today provide specific language explaining how breast density can influence the accuracy of mammography, and recommend patients with dense breasts talk to their health care provider. The FDA has also enhanced its ability to communicate directly with patients and their health care providers in cases where a facility did not meet quality standards.

Source: U.S. Food and Drug Administration| Read full story

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