Proposed rule would also tighten FDA regulation of mammogram facilities
WEDNESDAY, March 27, 2019 (HealthDay News) — Women with dense breasts who get mammograms must be told of their higher risk for breast cancer under new rules proposed Wednesday by the U.S. Food and Drug Administration.
The FDA proposal would also tighten its regulation of mammogram facilities, giving the agency the power to notify patients if problems are found at a center so that repeat mammograms can be done at another certified center.
The new rules mark the first time in more than 20 years that the FDA has proposed changes to key regulations for mammography facilities. Another proposed rule meant to provide more information to health care providers would add three additional categories for the assessments of mammograms, including one category called “known biopsy proven malignancy,” which would alert health care providers about cases in which cancer being evaluated by mammogram for treatment is already known and identified.
Under the proposed changes, patients and health care providers would also be given more detailed information about the mammography facility they use, the FDA said. Proposed changes meant to update mammography quality standards and better enable the FDA to enforce regulations and take action against violators include giving the agency the power to “directly notify patients and their health care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed,” the FDA wrote in a statement.
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