FDA Proposed Rule ‘Modernizes’ Mammography Screening, Includes Breast Density Reporting
May 2019 ~
The FDA announced that it is taking action to “modernize” breast cancer screening in the United States by amending the Mammography Quality Standards Act (MQSA) of 1992 with a new proposed rule.
The FDA is proposing amendments to key regulations that aim to help improve the quality of mammography services and expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making. According to the announcement, these changes would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services.
“Breast cancer is one of the most worrisome health concerns facing women,” Scott Gottlieb, MD, outgoing FDA commissioner, said in a prepared statement. “The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems early, when they can be effectively addressed. 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.”
Included in the proposed for MQSA regulation amendments, the FDA is seeking 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. The FDA is proposing specific language that would explain how breast density can influence the accuracy of mammography and would recommend patients with dense breasts talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation.
The proposed amendments also seek to enhance information provided to health care professionals through codifying three additional categories for the assessments of mammograms (“known biopsy proven malignancy,” “post-procedure mammograms for marker placement,” and “need prior mammograms for comparison”) to help identify cases where cancer being mammographically evaluated for therapy are already known and identified. Additionally, under the proposed regulations, both health care professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications.
The proposed amendments would also modernize mammography quality standards and better position FDA to enforce the MQSA regulations and take action when violations are found, including, but not limited to:
- The FDA can 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;
- Requiring that only digital accessory components specifically FDA approved or cleared for mammography be used, or that facilities use components that otherwise meet the requirements under the rule;
- Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.
“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” said the director of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D., “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 facillities’ deficiencies. This is intended to help ensure important information that could affect decisions about patient care—such as the potential need for further evaluation or a repeat of a mammogram—is communicated as quickly as possible.”
The complete text of the FDA’s proposal can be found on the Federal Register.