CDRH New - October 28, 2020

If your email program has trouble displaying this email, view as a webpage. CDRH New October 28, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 27, 2020. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations MassARRAY SARS-CoV-2 Panel (Agena Bioscience, Inc.) Re-Issued Emergency Use Authorizations QuantiVirus SARS-CoV-2 Test Kit (DiaCarta, Inc.) Updated Emergency Use Authorizations BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Xiamen Biotime Biotechnology Co., Ltd.) Helix COVID-19 Test (Helix OpCo LLC) 24 Hour Summary and Presentations posted for October 22, 2020 Patient Engagement Advisory Committee Meeting Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200026 added) Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 21, 2020 Automated External Defibrillators (AEDs) (Updated) Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date - Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff Federal Register: Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date FAQs on Testing for SARS-CoV-2 (Updated)

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