Regulatory Update: Mammography Quality Standards Act

By Daniel L. Freidlin, Esq. and Maureen P. Blazowski, Esq.
Thursday, November 14, 2019
Specialty: 

It is estimated that there will be 268,600 new cases of invasive breast cancer, exclusive of recurrent breast cancer, 62,930 cases of both ductal and lobular in situ breast cancer and 41,760 breast cancer deaths among U.S. women in 2019.

On March 29, 2019, the FDA released a proposed rule described as “landmark policy changes,” which would amend the mammography regulations that were issued under the Mammography Quality Standards Act of 1992, 21 C.F.R. Part 900. The amended rule would impose extensive new compliance requirements on all facilities across the United States that perform mammography studies. The proposed rule would also enhance FDA’s oversight of mammography facilities and broaden the scope of its enforcement actions.


Daniel L. Freidlin, Esq.


Maureen P. Blazowski, Esq.

Among the proposed amendments are mandatory breast density notification to both patients and providers, including specified language that would explain how breast density can influence mammography accuracy and recommend consultation between the patient and provider to discuss how breast density relates to breast cancer risk and their individual situation. As the FDA explains in its preamble, “[m]ammograms of breasts with higher density are harder to interpret than those of less dense breasts, because the dense tissue can obscure cancers.”i Dense breasts have also been identified as a risk factor for developing breast cancer.ii However, there is no standardized method for assessing breast density. Instead, the assessment is subjective and based on the opinion of the radiologist.iii The lack of consensus within the scientific community on the relationship between breast density and cancer risk, and the lack of reliable methods of assessing breast density have resulted in confusion among patients, radiologists, and ordering physicians.iv

A general rule is that patients should receive clear and actionable information to understand the significance of their mammographic findings in plain language. The American College of Radiology (ACR) has recommended against requiring breast density language in the lay summary for women with low breast density classifications as it considers such language to be nonactionable and could lead to unnecessary confusion or even cause undue concern. The ACR also urges the FDA to adopt language within the lay letter conveying density information which explicitly states that dense breasts are not abnormal.

The Proposed Rule notes that “additional screening of women with dense breasts can detect some additional cancers and reduce delays in treatment.”v However, The American College of Obstetricians and Gynecologists guidance urges gynecologists to act in compliance with their state laws on reporting, but “does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.”vi This may lead to a shifting paradigm in potential liability exposure between the radiologist who issues recommendations for higher level imaging and the clinician who may feel that higher level imaging is unnecessary for a particular patient in cases where the patient is later diagnosed with breast cancer.

The Proposed Rule will become effective 18 months following publication of the final rule in the Federal Register in October 2020. Facilities performing mammograms should review reporting and notification practices to ensure compliance once the new rule takes effect.


Daniel L. Freidlin, Partner and Maureen P. Blazowski, Of Counsel, are attorneys in the Medical Malpractice Defense Practice Group at Martin Clearwater & Bell LLP. For more information, visit mcblaw.com.