FDA wants to update mammography standards

The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers. The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards. The new proposal could help patients and providers make more informed decisions regarding care, and boost the FDA’s regulatory power over the safety and quality of mammography services, the agency said. The proposed amendments include: Adding specific language about breast density to the mammography results summary letter provided to patients and to the medical report sent to providers.  Mammograms of breasts with a higher proportion of dense fibroglandular tissue compared to fatty tissue can be difficult to interpret because the dense tissue can obscure signs of breast cancer, lower the sensitivity of the image and increase the risk of developing breast cancer. Codifying three more categories for mammogram assessment, including one titled “known biopsy-proven malignancy,” which would help identify for health care professionals cases in which cancer that is being evaluated by mammography for therapy has already been identified. Adding more detailed information about the mammography facility ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Featured Food & Drug Administration (FDA) Imaging Mammography News Well Oncology Regulatory/Compliance Women's Health nationalcancerinstitute Source Type: news