[Intl_DxMedPhys] New Alternative Standard for Breast Density Verbiage for Unilateral Exams

[Mary Ellen Jafari]

I just came across this.  We have previously received written approval from the FDA to modify the language in the breast density statement in mammography reports and lay letters for unilateral exams as described here, but the FDA has now issued an alternative standard to that effect, effective 7/11/2025.

MQSA Alternative Standard #26: Issuing a Report with a Breast Density Assessment that is Phrased in the Singular, or is Neither Singular Nor Plural | FDA<https://urldefense.com/v3/__https://www.fda.gov/radiation-emitting-products/regulations-mqsa/mqsa-alternative-standard-26-issuing-report-breast-density-assessment-phrased-singular-or-neither__;!!KGKeukY!wBoHFeeMWwXrd70u-8JEmdXI60Xv-cl4QzuRXRnhJsKWTMJyJBLKZbTjo3VDmH7ZheiOlwWqTBvnTYI-i3wWbuAlqbhgiRmJyht8I_9VhUHg3gI$ >

Mary Ellen Jafari, MS, DABR (D,N), MRSE, MRSO, FACR, FAAPM, CIIP
Chief Physicist and Regional Radiation Safety Officer

Kaiser Permanente
Southern California Permanente Medical Group Medical Imaging Technology and Informatics
199 S. Los Robles Ave., Pasadena CA 91101
626-430-1231 (office mobile)
Maryellen.Jafari at kp.org<mailto:Maryellen.Jafari at kp.org>

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