The Food and Drug Administration (FDA) has issued a final rule amending regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 to ensure quality mammography.
The updated MSQA requires that the mammography report include a summary for patients that indicates whether they have dense or not dense breasts, as well as information on the significance of breast density and how it may potentially limit mammogram results. The rule also establishes 4 categories for reporting breast tissue density in the mammography report that is provided to the health care provider. These include the following:
- The breasts are almost entirely fatty.
- There are scattered areas of fibroglandular density.
- The breasts are heterogeneously dense, which may obscure small masses.
- The breasts are extremely dense, which lowers the sensitivity of mammography.
Additional amendments include new and amended provisions related to mammography technology and improvements that enhance enforcement of quality standards. These amendments are required to be implemented by facilities within 18 months.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s Chief Medical Officer. “Since 1992, the FDA has worked to ensure patients have access to quality mammography. The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards. This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
FDA updates mammography regulations to require reporting of breast density information and enhance facility oversight. News release. US Food and Drug Administration. Accessed March 9, 2023. https://www.prnewswire.com/news-releases/fda-updates-mammography-regulations-to-require-reporting-of-breast-density-information-and-enhance-facility-oversight-301768041.html.