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The Food & Drug Administration has updated the Mammography Quality Standards Act (MQSA) to make patient breast density notification a federal requirement.

Cancer Risk

Breast Density

Dense breast tissue is common but linked to an increased risk for breast cancer. As density increases, mammography accuracy decreases.

Spotlighting breast density

What you need to know


Required "inform" language

Mammography summary lay letter must inform patient if they have dense or non-dense breast tissue.


Assessment in referring provider reports

Reports for healthcare providers must include an assessment of breast density using the BI-RADS® 5th Edition categories.

Quick Guide

FDA ruling summary, checklist, and Volpara support.

Get ready now

Your checklist for compliance by September 2024

Review MQSA rule update

Contact the MQSA program for assistance

Consider state-level language for insurance coverage

Update letter and report templates in mammography reporting software

Request a review from your legal team

Distribute referrer communication about report language changes

Train patient-facing staff on new language

Evaluate educational content


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