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<p class="MsoNormal">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.<o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><a href="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$">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</a><o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Mary Ellen Jafari, MS, DABR (D,N), MRSE, MRSO, FACR, FAAPM, CIIP<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Chief Physicist and Regional Radiation Safety Officer<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Kaiser Permanente<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">Southern California Permanente Medical Group Medical Imaging Technology and Informatics<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">199 S. Los Robles Ave., Pasadena CA 91101<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif">626-430-1231 (office mobile)<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:"Calibri",sans-serif"><a href="mailto:Maryellen.Jafari@kp.org"><span style="color:#467886">Maryellen.Jafari@kp.org</span></a><o:p></o:p></span></p>
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