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Hello, I saw this on Aunt Minnie. I use the MAUDE website to review MR safety events and I am sure others on this list do as well. FDA moves to quickly replace adverse event reporters AuntMinnie. com staff writers Mar 11, 2026 The U. S. Food and</div>
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<p class="MsoNormal">Hello, I saw this on Aunt Minnie. I use the MAUDE website to review MR safety events and I am sure others on this list do as well.<o:p></o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><b>FDA moves to quickly replace adverse event reporters<o:p></o:p></b></p>
<p class="MsoNormal"><a href="https://urldefense.com/v3/__https://www.auntminnie.com/home/contact/15554467/auntminniecom-staff-writers__;!!KGKeukY!wCb1tg8vD_T8OkFkzn3XWzwClkO46Inl05UcpoFAbT8YQ4IwUfD9sz6pyR6kPN8TZ5cN8T5xcuIUzeaJCqjZGIcY2vUU-d1PPy5PqBS6rwnZrUg$">AuntMinnie.com staff writers</a><o:p></o:p></p>
<p class="MsoNormal">Mar 11, 2026<o:p></o:p></p>
<p class="MsoNormal">The U.S. Food and Drug Administration (FDA) has launched a single platform for analyzing adverse event reports across all product categories the agency regulates.<o:p></o:p></p>
<p class="MsoNormal">With the new FDA Adverse Event Monitoring System (AEMS), the FDA Adverse Event Reporting System (FAERS), which contained reports for drugs, biologics, cosmetic products, and color additives, will be among the first to be replaced. The Manufacturer
and User Facility Device Experience (MAUDE) database for medical devices is scheduled for replacement in May.<o:p></o:p></p>
<p class="MsoNormal">AEMS consolidates reporting that was previously spread across seven databases, which collectively cost the agency approximately $37 million per year to operate, according to the agency. The FDA expects to save approximately $120 million
over the next five years with the new system.<o:p></o:p></p>
<p class="MsoNormal">"Transparency around adverse event reports submitted by patients, consumers, clinicians, and manufacturers is a critical component of the FDA’s postmarket surveillance capability," the FDA said in its March 11 announcement.<o:p></o:p></p>
<p class="MsoNormal">By the end of May 2026, the AEMS system will contain real-time adverse event reports for all FDA-regulated products, the FDA added, noting that it processes approximately six million adverse event reports per year.<o:p></o:p></p>
<p class="MsoNormal"><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>
<p class="MsoNormal"><o:p> </o:p></p>
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