publication date: Mar. 29, 2019

Drugs & Targets

FDA advances policy changes to modernize mammography services

FDA announced steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.

The proposed rule is posted here.

For the first time in more than 20 years of regulating mammography facilities, the agency is proposing amendments to key regulations that would help improve the quality of mammography services for millions of Americans.

These actions would expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making. It would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.

FDA’s proposal would amend regulations issued under the Mammography Quality Standards Act of 1992, which Congress passed to ensure quality mammography for early breast cancer detection. The MQSA authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards to help ensure mammography facilities provide quality care.

Among the proposed amendments to improve communication and medical decision making is the addition of breast density information to the mammography lay summary letter provided to patients and to the medical report provided to their referring health care professionals. Mammograms of dense breasts—breasts with a higher proportion of fibroglandular tissue compared to fatty tissue—can be difficult to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image. Dense breasts have also been identified as a risk factor for developing breast cancer.

FDA is proposing specific language that … Continue reading FDA advances policy changes to modernize mammography services

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