FDA Stops Emergency Use Authorization Review of SQI Diagnostics Inc. RALI-Dx IL-6 Severity Triage Test for Covid-19 Patients
July 23, 2021 at 09:30 pm
SQI Diagnostics Inc. announced that FDA will not continue its review of SQI's submission of the RALI-Dx™ IL-6 Severity Triage Test for Emergency Use Authorization under the "Tests for Management of COVID-19 Patients" category. The agency cites a high volume of EUA requests and its prioritization of EUA reviews according to factors including the public health need for the product and shortages of critical devices during the pandemic. The FDA has encouraged SQI to submit an application under a non-EUA regulatory pathway.