The FDA proposed requiring mammogram providers to notify women with dense breast tissue about how the condition could affect the accuracy of their mammograms and recommend they talk with doctors about whether they should have more tests to check for cancer
The proposal would update regulations issued under the 1992 Mammography Quality Standards Act, which authorized federal oversight of the more than 8,000 mammography facilities in the U.S. Those rules involve the accreditation of the facilities, as well as annual inspections and enforcement of mammography quality rules.
The proposal would modernize the agency’s oversight of mammography services “by 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,” FDA Commissioner Scott Gottlieb said in a statement.
In addition, the changes would allow the FDA to directly notify patients and their healthcare providers if a facility did not meet quality standards and a repeat test might be needed, the agency said.Nancy Cappello, who led the push for legislation to provide women with more information about breast density, died in November 2018 of complications from cancer treatment.
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