The Food and Drug Administration is proposing to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).  We are proposing updates to modernize the regulations by incorporating current science and mammography best practices.  These updates would improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.

Regulatory Impact Analysis

Mammography Quality Standards Act; Amendments to Part 900 Regulations (PDF - 413KB)

Federal Register: 84 FR 11669, March 28, 2019

Docket: FDA-2013-N-0134