CDRH New - January 13, 2021

If your email program has trouble displaying this email, view as a webpage. CDRH New January 13, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 12, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations RapCov Rapid COVID-19 Test (ADVAITE, Inc.) EliA SARS-CoV-2-Sp1 IgG Test (Phadia AB) VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.) Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 6, 2021 Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan FDA News Release: FDA Releases Artificial Intelligence/Machine Learning Action Plan Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated) Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated) Federal Register: Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee

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