FDA Modernizes Breast Cancer Screening Regulations

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For the first time in more than 25 years, the Food and Drug Administration is proposing changes to key mammography regulations to improve the quality and safety of breast cancer screening for millions of Americans. Under the new regulations, women and their health care providers will get more information to help them make better-informed decisions about breast health.

Since 1992, the FDA has overseen the accreditation, certification, and annual inspection of mammography facilities, and enforces standards to ensure the facilities provide high-quality care.

In a press release, FDA Commissioner Scott Gottlieb, M.D. stated that the agency is “capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting. We’re committed to making sure patients have access to high quality mammography.”

The proposed regulations will require breast density information to be provided in post-mammography patient letters and medical reports. In women with dense breasts, mammograms can be difficult to interpret and signs of breast cancer may be missed. The addition of three new categories for assessing mammogram results is also in the proposal, including “known biopsy proven malignancy,” which would identify cases where known cancer is being evaluated by mammography.

The full proposal is available online for public comment for 90 days.