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FDA Proposes Major Changes to Mammography Regulations

Posted 27 March 2019 | By Zachary Brennan 

FDA Proposes Major Changes to Mammography Regulations

The US Food and Drug Administration (FDA) on Wednesday proposed a new rule that would modernize mammography regulations and require mammography facilities to provide patients with more information on breast density.

The changes come as, according to the National Cancer Institute (NCI), about 12.4% of women will be diagnosed with breast cancer at some point during their lifetime. In 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease, according to NCI.

Specifically, the proposal requires that the lay summary provided to patients after mammograms would “identify whether the patient has low or high density breasts and include a prescribed paragraph on the significance of breast density. They would also establish four categories for reporting breast tissue density in the mammography report that is provided to the patient’s referring healthcare provider,” FDA said.

FDA Principal Deputy Commissioner Amy Abernethy said: “Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy.”

Dana Smetherman, chair of the American College of Radiology Breast Imaging Commission, told Focus in a statement: "Screening technology, breast imaging practices, and our knowledge of breast cancer biology have advanced over the years. It is understandable that the FDA would revisit these regulations. While breast density reporting requirements would be new at the federal level, many states now have breast density notification requirements. Radiologists are complying with those laws. The inclusion of breast density information in mammography reports to patients’ referring physicians has been in place for many years - based on the American College of Radiology BI-RADS classification system. The ACR supports providing patients and their doctors with accurate, actionable information to better diagnose and treat those in our care. We look forward to working with FDA through the details of this process to ensure that any updates to FDA regulation improve patient care and efficiency of care provided."

In addition to the new changes on breast density, the proposal seeks to address changes in mammography technology, including updating equipment and quality control provisions in the regulations, enhancing the enforcement of quality standards and improving the way mammography results are categorized, reported, retained and transferred to patients and health care providers.

For instance, the proposal would add a specific, required timeframe for mammography facilities to deliver reports to health care providers and lay summaries for patients whose mammograms have either “Suspicious” or “Highly suggestive of malignancy” final assessment categories, which FDA said “could lead to earlier definitive tissue diagnosis of malignancy and earlier start of treatment, and avoid, for the patient, the anxiety of a protracted waiting period.”

The new rule would also change the explanatory language in the “benign” final assessment category “to promote greater consistency and accuracy in the use of the category, and add three new categories of mammographic assessment to the existing categories in the regulations, which would allow mammography facilities to more precisely classify and communicate findings,” the final rule says.

Meanwhile, mammography facilities would be required to implement certain policies to minimize the loss of mammography images and reports because such losses can negatively impact clinical care. Specified timeframes on when such reports must be disseminated to health care providers and patients are also discussed.

FDA, under the proposal, can also directly notify patients and their health care professionals that mammography at a specific facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be necessary.

“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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.” 

Proposed Rule


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