FDA Amends Mammography Quality Standards Act

By: Joseph Cupolo
Posted: Monday, September 23, 2024

In a recent ruling, the U.S. Food and Drug Administration (FDA) has finalized regulations intended to improve the delivery of mammography services by strengthening the communication of health-care information through the Mammography Quality Standards Act (MQSA). This step is expected to enable more informed decision-making by patients and providers (by requiring facilities to provide them with additional health information).

The final rule established federal standards designed to categorize breast tissue density, enhance communication to patients, and raise the bar for accreditation and facilities. The MQSA and its implementing regulations do not include clinical practice guidelines. The interpretation of the imaging findings remains the responsibility of the qualified interpreting physician.

In addition to requiring mammography reports, regulations stipulate the inclusion of an overall evaluation of findings or next steps for an incomplete workup, breast density assessment, and patient lay summaries. Further amendments include requiring presentation of mammograms for interpretation in the modality in which they were originally produced, not copied or digitized from hardcopy original images. Such unoriginal images may adversely affect the accuracy of interpretation and prohibit accreditation bodies from accepting an application for accreditation from a facility that has failed to become accredited after three consecutive attempts until 1 year after the most recent accreditation failure.

For more details on this recent ruling amendment to the MQSA, see the FDA statement.

U.S. Food and Drug Administration

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