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

Lexology March 13, 2023
Reed Smith LLP

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 the updated rule “modernize the regulations by incorporating current science and mammography best practices.” The rule 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 is...

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