FDA's Proposed Rule on Mammography Standards

June 23, 2019

Download this Public Interest Comment (PDF)


Early detection of breast cancer can save lives. Mammography is one of the screening tools that has contributed to reductions in breast cancer mortality. FDA has a unique role in mammography and should be commended for proposing to update its rules, particularly for those updates that reflect new technologies, such as the provisions related to digital mammography that update old regulatory terms like “x-ray film.” The proposed rule’s breast density notification, however, raises issues of state preemption; lessons that can be learned from testing, evaluation, and assessment of prior state action; and analysis of distributional and equity effects. FDA should consider these issues before it proceeds.


Mammography is an x-ray technology that, like other imaging techniques, enables detection of breast cancer. Following medical advancements in breast cancer detection in the 1960s, mammography gained traction as a valuable tool in patient care. By the 1980s, its use was widespread but there were reports of misdiagnoses and other quality issues. After a period of industry self-regulation and an effort to use grant funding from the Centers for Disease Control (CDC) and Medicare payment policy to improve quality, Congress stepped in to regulate mammography more directly. It gave that responsibility to FDA in the 1992 Mammography Quality Standards Act (MQSA), which has been amended twice since then, most recently in 2004. Under MQSA, it is unlawful to operate a mammography facility unless it is certified by FDA. The MQSA is distinct from FDA’s other authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), which apply generally to mammography equipment as a medical device. Under the FD&C Act, FDA regulates medical devices using restrictions like premarket review, to evaluate whether certain medical devices may be marketed, and postmarket surveillance, to monitor products and potentially to intervene after FDA has approved them for sale. The MQSA, in contrast, applies to mammography facilities in a broader way (e.g., licensure of personnel, patient reporting requirements). Reflecting the scope of FDA’s statutory role in mammography, a 2002 GAO Report characterized FDA as having “major oversight responsibilities” under the MQSA. FDA’s most recent final rule on mammography was issued in 2002. This new proposed rule contains over a dozen, wide-ranging regulatory changes related to patient and physician reporting, mammogram technology, personnel certification, recordkeeping, facility operations, and more.