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FDA is amending its regulations governing mammography. The amendments will update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and healthcare providers.

Statement of Need:

FDA is updating the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the FD&C Act. FDA is taking this action to address changes in mammography technology and mammography processes.

FDA is also updating to modernize the regulations by incorporating current science and mammography best practices, including addressing breast density reporting to patients and healthcare providers. These updates are intended to improve the delivery of mammography services.

Summary of the Legal Basis:

The MQSA (Pub. L. 102-539) is codified under the Public Health Service (PHS) Act (42 U.S.C. 263b; section 354 of the PHS Act).  Under the MQSA, all mammography facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by FDA (or an approved State certification agency) to provide mammography services (42 U.S.C. 263b(b)(1), (d)(1)(iv)).  FDA is amending the mammography regulations (set forth in part 900 (21 CFR part 900)) under section 354 of the PHS Act (42 U.S.C. 263b), and sections of the FD&C Act (sections 519, 537, and 704(e); 21 U.S.C. 360i, 360nn, and 374(e)).

Alternatives:

The Agency will consider different options so that the health benefits to patients are maximized and the economic burdens to mammography facilities are minimized.

Anticipated Costs and Benefits:

The benefits and costs associated with this final rule include qualitative benefits related to reduced mortality, morbidity and breast cancer treatment costs resulting from the breast density reporting requirements.  Additional benefits that we are not able to quantify include improvements in the accuracy of mammography by improving quality control and strengthening the medical audit, and effects on morbidity.

Risks:

None.