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| 3 minutes read

FDA unveils major new changes to its mammography quality standards regulations, and mandates reports to patients about their breast density

On March 10, 2023, the U.S. Food and Drug Administration (FDA) published in the Federal Register a long-awaited final rule to update regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). In doing so, FDA said their updated rules "modernize the regulations by incorporating current science and mammography best practices." These new regulations will impact services at approximately 8,700 mammography facilities across the United States.

The new rule has grabbed headlines from major national media like the New York Times and the Washington Post. The MQSA has long required that, in addition to the clinically-based radiologist mammography report prepared for the patient's physician, a second report written in lay terms (i.e., written in readable and easily comprehensible language) and sent to the patient. The new final rule will require that lay report to identify whether the patient has dense or non-dense breast tissue. 

Going forward, when the final rule is effective, the lay report for every mammography patient must include a paragraph on the significance of breast density. For patients with low breast density, the lay report received by the patient will read: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation." For patients with dense breast, the lay report states: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

About half of the population of women over 40 have dense breast tissue. Breast density makes detection of breast cancer using mammography harder. Currently, 38 states and the District of Columbia require some level of breast density notification after a mammogram. But not all of the state laws require mammography patients be specifically told about their own breast density. The FDA's new rule will change that when it becomes effective.

The rule establishes four categories for reporting breast tissue density in the mammography report that is provided to the patient's healthcare provider. The radiologist's final written report of the results of the mammographic examination will include information concerning an overall assessment of the patient's breast density, classified in one of the following categories: (A) “The breasts are almost entirely fatty.” (B) “There are scattered areas of fibroglandular density.” (C) “The breasts are heterogeneously dense, which may obscure small masses.” (D) “The breasts are extremely dense, which lowers the sensitivity of mammography.”

Under the MQSA, all mammography facilities, except facilities of the Department of Veterans Affairs (VA), must be accredited by an approved accreditation body like the American College of Radiology and certified by FDA (or an approved State certification agency) to be eligible to provide mammography services. FDA is strengthening it's quality requirements in a number of ways. Among those new requirements:

- The mammograms submitted to radiologists for interpretation must be presented in the mammographic modality in which they were originally produced, and not be copied or digitized from hardcopy original images;

-Once the rule is effective, accreditation bodies may not accept an application for accreditation from a facility that has failed to become accredited after three consecutive attempts until 1 year after the most recent accreditation failure;

-Before a facility closes or no longer provides mammography services, it must make arrangements for access by patients and healthcare providers to mammography images and reports;

-The explanatory language in the assessment category for "benign" findings has been modified to promote greater consistency and accuracy;

-Faster time frames (within 7 calendar days of the final interpretation of the mammograms) have been adopted for when facilities must send mammography reports to healthcare providers and the lay report when mammography findings are either “suspicious” or “highly suggestive of malignancy;"

-Since screening mammography patients can self-refer, mammography facilities that accept patients who do not have a healthcare provider shall maintain a system for referring such patients to a healthcare provider when clinically indicated, which shall include when such patients' mammogram assessment is either probably benign, suspicious, or highly suggestive of malignancy; 

-Each mammography facility must implement policies and procedures to minimize the loss of mammography images and reports; and

-The minimum information that facilities must collect during the mammography medical outcomes audit is clarified.

The new rule will be in effect 18 months after the date of publication. Consequently, mammography facilities will need to be in compliance with the amended MQSA regulations in the final rule by September 10, 2024.

Change the explanatory language in one final assessment category (“Benign”) 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.


fda, mammography, breast density, health care & life sciences