FDA Approves Alternative Standard #26 – New Flexibility in Breast Density Reporting under MQSA
On July 11, 2025, the FDA approved MQSA Alternative Standard #26, allowing additional flexibility in how radiologists phrase breast density findings in the provider report (radiologist’s report). This change does not affect the required patient lay summary wording but allows updated phrasing options for BI-RADS density categories in the report of test results.
This article summarizes what’s changed, what your options are, and how to stay compliant.
What Has Changed?
Under the previous MQSA Final Rule (effective September 10, 2024), radiologist reports were required to use specific plural phrases to describe breast density (e.g., “The breasts are heterogeneously dense…”).
Now, under Alternative Standard #26, MQSA-regulated facilities can use plural, singular, or label-style language when reporting density in the radiologist’s report.
This provides additional flexibility, especially for unilateral studies or facilities using structured templates.
Approved Wording Options for Radiologist Reports
You may now use any of the following eight FDA-approved breast density phrasings:
BI-RADS Category |
Plural (Original) |
Singular |
Label-Style (Neither) |
| A – Almost entirely fatty | “The breasts are almost entirely fatty.” | “The breast is almost entirely fatty.” | “Breast Density: Almost entirely fatty” |
| B – Scattered fibroglandular | “There are scattered areas of fibroglandular density.” (unchanged) | (Same as plural) | “Breast Density: Scattered areas of fibroglandular density” |
| C – Heterogeneously dense | “The breasts are heterogeneously dense, which may obscure small masses.” | “The breast is heterogeneously dense, which may obscure small masses.” | “Breast Density: Heterogeneously dense, which may obscure small masses” |
| D – Extremely dense | “The breasts are extremely dense, which lowers the sensitivity of mammography.” | “The breast is extremely dense, which lowers the sensitivity of mammography.” | “Breast Density: Extremely dense, which lowers the sensitivity of mammography” |
🔗 Official Source: FDA MQSA Program🔗 FDA Notice: Alternative Standard #26
What Remains the Same?
The patient lay summary (lay letter) must still use the FDA’s standard dense/not dense language, unchanged from the MQSA Final Rule.
The BI-RADS category assigned (A, B, C, D) and related clinical recommendations remain the same.
- All facilities must continue to provide patients with the appropriate FDA-prescribed paragraph based on whether the tissue is dense (C or D) or not dense (A or B).
Why This Matters
✅ Improved Clarity
Using singular phrasing is especially helpful for unilateral exams (e.g., after mastectomy or reconstruction), preventing confusion when referring to a single breast.
✅ More Template Flexibility
Facilities using structured reporting systems or EHR templates may prefer label-style phrasing, which is now officially approved.
✅ Continued Compliance
All phrasing options listed above are fully MQSA-compliant. You may update your templates without submitting for separate approval.
Recommendations for Your Facility
To implement this change smoothly, we suggest:
Update Your Report Templates
Choose and implement your preferred phrasing (plural, singular, or label-style) in the radiologist report system.
Leave Lay Letters Unchanged
Continue to use the standardized FDA language for patient letters based on breast density classification.
Train Staff and Radiologists
Educate reporting physicians about the new phrasing options—especially the applicability of singular phrasing for unilateral studies.
Document and Audit
Maintain internal documentation noting which version your site uses and ensure consistency across cases.
Sample Template Use
Scenario |
Recommended Density Phrase |
Patient Summary |
| Bilateral screening | “The breasts are heterogeneously dense…” | Standard “dense” letter |
| Right breast only (post-mastectomy) | “The breast is extremely dense…” | Standard “dense” letter |
| Structured report | “Breast Density: Scattered areas of fibroglandular density” | Standard “not dense” letter |