FDA Updates Mammography Regulations with Breast Density Notification Requirement

The FDA has updated its mammography regulations to require reporting of breast density information by facilities, according to a statement by the organization on March 9, 2023.¹ This update amends regulations issued under the Mammography Quality Standards Act (MQSA) of 1992, legislation passed to ensure quality mammography, which is critical for early detection of breast cancer. The MQSA allows FDA oversight of mammography facilities, including their accreditation, certification, annual inspections, and enforcement of standards to aid in ensuring these facilities are providing quality care to patients.

The updates will not only increase patients’ awareness of their breast density, but they will also strengthen the FDA’s oversight and enforcement of facilities as well as help physicians better assess and categorize mammograms.

Hilary Marston, MD, MPH

“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. “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.”

The amendments include specific language explaining how breast density can affect the accuracy of mammography and recommend that patients with dense breast tissue talk to their healthcare provider.

The updated regulations will also enhance the FDA’s oversight of mammography facilities and the agency’s ability to communicate directly with patients and their healthcare providers in cases where a facility did not meet quality standards and is failing to communicate adequately with patients about its deficiencies. This is intended to promote better communication of vital information that could affect decisions regarding patient care, such as the potential need for additional tests or evaluation.

JoAnn Pushkin, Executive Director, DenseBreast-info, Deer Park, NY, issued the following statement regarding the updates: “It’s been over 10 years since my request to [FDA] to consider the requirement that women be informed about their breast density after their mammogram and over 10 years since an FDA advisory committee agreed that women certainly should be. Too many patient ‘density inform’ advocates are no longer with us to join me in an exhale of relief that all US women will now be told about their breast density after their mammograms. That their tragedies—of hidden cancers finally found when no longer early stage—may be prevented from wreaking havoc on other families.”

States will have until September 10, 2024, to comply with this new rule. Once the rule goes into effect, 1 of 2 Federal density notification statements (“not dense” or “dense”) will be required in all patient letters as follows²:

• Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk for developing breast cancer. Add “not dense” or “dense” text below:
• Not dense: Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.
• Dense: Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.

Current individual state “inform” reporting language is available at https://densebreast-info.org/legislative-information/state-legislation-map/.

References

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. DenseBreast-info. FDA national reporting standard. https://densebreast-info.org/legislative-information/national-reporting-standard/. Accessed March 14, 2023.