FDA Requires Breast Density Information, New Mammography Regulations

The newest FDA mammography regulations include requirements for sharing information on breast density, enforcing more extensive FDA oversight of mammography facilities, and adding more tools for providers to assess and interpret mammograms.

Within 18 months, the FDA is expected to make significant provisions across three different areas. First, the organization plans to regulate mammography technology and update outdated equipment. Technology will also undergo quality control provisions moving forward.

Beyond technology, the newest FDA regulations will require the organization to enforce more robust oversight strategies. Among this more vigorous enforcement, the organization will require that mammography facilities release results to providers for interpretation in the original mammography method, minimizing the risk of inaccurate interpretation.

Additionally, the regulations will enforce more robust accreditation protocols, implementing a mandatory one-year waiting period for facilities that have failed accreditation three times.

The final category of revisions focuses on improving the analysis and sharing of mammography reports, requiring that all reports include information on the facility so that providers can communicate directly with the facility when necessary.

Most notably, the updates require that mammography facilities report breast density information to patients and providers. Rather than using the terms high density and low density, facilities will shift to describing breasts as dense and not dense. Additionally, facilities are expected to provide one of the following classifications for overall breast density:

• Entirely fatty breasts
• Scattered areas of fibro-glandular density
• Heterogeneously dense breast, which may obscure small masses
• Extremely dense breasts, lowering the sensitivity of mammography

The new regulations are amendments to the current Mammography Quality Standards Act of 1992. The Act aims to improve mammogram quality and facilitate early cancer detection. Generally, the mammography guidelines allow the FDA to monitor mammography facilities by managing accreditation, certification, annual inspections, and standards enforcement.

“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, in the press release.

“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,” Marston continued.” 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.”