CDRH New - April 27, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 24-26, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack Autiobio Diagnostics Co. Ltd. Anti-SARS-CoV-2 Rapid Test Southwest Regional PCR Laboratory LLC. dba MicroGen DX COVID-19 Key Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay AIT Laboratories SARS-CoV-2 Assay Updated Emergency Use Authorizations: Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co. Ltd) NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.) ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (ScienCell Research Laboratories) SARS-CoV-2 Fluorescent PCR Kit (Maccura Biotechnology (USA) LLC) SARS-CoV-2 Test (Exact Sciences Laboratories) Face Masks (non-surgical) - Reissuance Hologic, Inc. Panther Fusion SARS-CoV-2 Assay - Added Letter Granting EUA Amendment(s) (April 24, 2020) Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff FDA Activities Related to Essure (Updated) Problems Reported with Essure (Updated) FDA News Release: FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure FAQs on Diagnostic Testing for SARS-CoV-2 (Updated 4/24) FAQs on the Emergency Use Authorization for Face Masks (Non-Surgical)