CDRH New - May 5, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 1-4, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: Roche Diagnostics Elecsys Anti-SARS-CoV-2 EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG) BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1) Bio-Rad Laboratories, Inc Bio-Rad SARS-CoV-2 ddPCR Test Protective Barrier Enclosures Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device multiFiltrate PRO System and multiBic/multiPlus Solutions (Fresenius Medical Care) New York SARS-CoV Microsphere Immunoassay for Antibody Detection (Wadsworth Center, New York State Department of Health) Altru Dx SARS-CoV-2 RT-PCR assay (Altru Diagnostics, Inc.) Updated Emergency Use Authorizations: VitalConnect, Inc., VitalPatch Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG IFU Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital Childrens-Altona-SARS-CoV-2 Assay EUA Summary BioFire COVID-19 Test (BioFire Defense, LLC) Accula SARS-Cov-2 Test (Mesa Biotech Inc.) FDA Fact sheet - Antibody Test Oversight and Use for Covid-19 Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff EUA Authorized Serology Test Performance April 2020 PMA Approval List Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180055, DEN180065 and DEN190026 added) FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)         Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff Federal Register: Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide MQSA National Statistics Medical Gloves for COVID-19: Manufacturing, Purchasing, Importing and Donating Gloves During the Public Health Emergency