FDA Updates Regulations on Mammography

Interviewer: Lauri R. Graham; Interviewee: David D. Lee, MD


June 14, 2019

Editorial Collaboration

Medscape &

For the first time in more than 20 years of regulating mammography facilities as part of the Mammography Quality Standards Act of 1992 (MQSA), the US Food and Drug Administration (FDA) is proposing amendments to key regulations in an effort to improve the quality of mammography services. These actions would expand the information that mammography facilities must provide to patients and healthcare professionals, allowing for more informed medical decision-making. They would also modernize mammography quality standards and better position the FDA to enforce regulations that apply to the safety and quality of mammography services. The proposed rule is available online for public comment until June 26, 2019. Medscape spoke to David D. Lee, MD, director of the Division of Mammography Quality Standards at the FDA, about these landmark policy changes.

David D. Lee, MD

What are the overall major changes to mammography reporting in the proposed rule?

The proposed rule updates the information required in mammography reports for both patients and healthcare providers. They will now have to include breast density information and extended mammography facility identification information. The proposed rule also adds three mammography assessment categories, one of which is a new category titled "Known biopsy-proven malignancy" for patients whose cancer is already known and is being mammographically evaluated for therapy. Reports must also be made available to patients and healthcare professionals within a specific time range.

Other amendments allow the FDA or state certifying agencies to directly contact patients and healthcare providers if a facility is found to provide mammography services that are not of acceptable quality but that facility is unable or unwilling to perform this notification. The proposed amendments also require that facilities implement policies and procedures to minimize the possibility of loss of patient images and records. Facilities are currently required to calculate medical outcomes data, and proposed additions to these data include the metrics of cancer detection rate, recall rate, and positive predictive value, which is the percentage of patients with positive results from screening mammograms who are diagnosed with breast cancer within 1 year of the date of the mammographic examination.

Another proposal affects facilities failing to become accredited after three consecutive attempts. They will not be allowed to apply for accreditation again until 1 year from the date of the most recent accreditation failure.

Why are these changes being proposed now?

This is part of our overall commitment to protecting the public health and advancing the health of women. We are proposing these amendments to update and modernize our oversight by capitalizing on a number of important advances in mammography since the MQSA was implemented, such as 2D and 3D digital screening tools and more uniform breast density assessment.