Signify Premium Insight: US-FDA’s Standardised Appeal

Published: April 6, 2023

Last month the US-FDA added a new rule to the Mammography Quality Standards Act, adding detail on the reporting of breast density in screening programmes.

The new guidance means that, from September 2024, breast screening centres will be required to notify patients about the density of their breasts, a physiological feature which can influence the accuracy of mammography and a risk factor for developing breast cancer. Providers will also have to convey this density information in specific, non-technical language.

The new rules also standardise the reporting of breast density, establishing four categories to identify breast density levels in the mammography report. Such federal guidance has been on the cards for several years, so what can be expected now it is enacted?

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