The FDA is proposing a requirement that mammography facilities provide information on risks associated with dense breasts to help women make better decisions regarding breast health, according to a press release from the agency.
Other proposed FDA changes include amendments to the Mammography Quality Standards Act of 1992, which grants the agency oversight of mammography facilities. The amendments would allow the FDA to alert patients and health care professionals when a mammography facility does not meet quality standards.
“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our 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, MD, said in a press release. “We’re committed to making sure patients have access to high-quality mammography. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”
One proposed amendment to FDA regulations would add breast density information to the lay summary letter given to patients undergoing mammography and to the medical report given to their health care professionals.
The FDA is proposing a requirement that mammography facilities provide information on risks associated with dense breasts to help women make better decisions regarding breast health.
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Specific language would explain how breast density affects the accuracy of a mammography and would recommend patients with dense breasts consult their provider about the relationship between high breast density and risk for breast cancer.
The FDA also proposes codifying three more categories for mammogram assessment, including “known biopsy proven malignancy.”
Changes to the Mammography Quality Standards Act would allow the FDA to:
- directly notify patients and health care professionals when a mammography facility does not meet quality standards and that the mammogram may need to be reevaluated or repeated at a different facility;
- require that only FDA-approved digital accessory components be used for conducting a mammography; and
- strengthen record-keeping rules to let patients access and transfer mammography results easily.
The proposed amendments are available online for public comment up to 90 days after publication at www.regulations.gov.
“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their health care professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facilities’ deficiencies.”