FDA Updates Mammography Regulations to Require Reporting of Breast Density Information

April 2023, Vol 14, No 2

The FDA has issued a final rule intended to ensure patients are better informed about their breast tissue density when undergoing mammography. The rule updates regulations first issued in the 1990s under the Mammography Quality Standards Act (MQSA) to oversee mammography facilities and improve breast cancer testing.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect, and treat cancer,” Hilary Marston, MD, MPH, Chief Medical Officer of the FDA, said in a press release.1 “Since 1992, the FDA has worked to ensure patients have access to quality mammography. The impact of the [MQSA] 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.”

Under the new rule, mammography providers are required to inform patients about the density of their breasts. Research indicates that approximately 50% of women in the United States aged ≥40 years tend to have high-density breast tissue, which not only makes it more difficult for mammography tests to detect breast cancer, but also puts these individuals at higher risk for developing the disease.2 The final rule addresses this issue by providing specific language about how breast tissue density can affect mammography tests and recommending that patients with high breast tissue density talk to their healthcare provider about their breast density and risks for breast cancer.

Although most certified mammography facilities meet quality standards, the final rule gives the FDA the ability to communicate with mammographers directly, and if needed, to talk to patients and their healthcare providers about mammography facilities that do not meet quality standards and are not adequately communicating with patients about their breast tissue density. This is intended to promote better communication of important information that could affect decisions regarding patient care, such as the need for additional tests or evaluation.

Mammography facilities have until September 24, 2024, to comply with the final rule.

Addressing Barriers to Care

Unfortunately, even if patients learn that they have dense breasts and it is suggested by their providers that they undergo additional screenings, the cost of these tests may prevent them from getting the care they need. This issue continues to be a topic of discussion among health advocates and policy makers.

“This long-awaited FDA rule (an amendment to the [MQSA]) is an important step in providing patients actionable information to increase their chances of finding breast cancer early when it is most treatable and outcomes are best,” wrote Clare Dougherty, Chief Executive Officer, The Brem Foundation, a nonprofit organization aimed at maximizing women’s chances of finding early, curable breast cancer through education, advocacy, and access programs for low-income communities, in a statement.3

“Today’s published rule sidesteps the topic of insurance coverage, expressing that it is not within the scope of the authority of the MQSA. Yet, the out-of-pocket costs for screening beyond mammography—sometimes referred to as the ‘hidden costs’ of breast cancer diagnosis—are often prohibitive and a barrier to access. This barrier contributes to the vast disparities in breast cancer mortality rates among people of color in the US. The Brem Foundation is actively working with legislators to support the passage of The Find It Early Act, which would require both private and government insurers to cover these costs, leveling the playing field for patients to access thorough breast cancer screening that can—and does—save lives,” she added.

The Find It Early Act was introduced into Congress on December 13, 2022. If passed, it would require insurers to cover additional breast imaging after a mammogram, with no out-of-pocket costs for women with dense breasts or at higher risk for breast cancer.4


  1. US Food and Drug Administration. FDA updates mammography regulations to require reporting of breast density information and enhance facility oversight. March 9, 2023. www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance. Accessed March 12, 2023.
  2. The Centers for Disease Control and Prevention. What does it mean to have dense breasts? Updated September 26, 2022. www.cdc.gov/cancer/breast/basic_info/dense-breasts.htm. Accessed March 17, 2023.
  3. The Brem Foundation. A lifesaving standard: FDA announces new breast density notification rule. March 9, 2023. https://stories.bremfoundation.org/fda-breast-density-rule. Accessed March 17, 2023.
  4. BreastDense-info.org. Find It Early Act. https://densebreast-info.org/legislative-information/find-it-early-act/. Accessed March 17, 2023.

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