CDRH New - April 22, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 21, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: SARS-CoV-2 Molecular Detection Assay (Mayo Clinic Laboratories, Rochester, MN) Sterilucent, Inc. Sterilization System Allplex 2019-nCoV Assay (Seegene, Inc.) Updated Emergency Use Authorizations: TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.) Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.) cobas SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS)) Ventilator EUA Interactive Review Template Nonbinding Feedback After Certain FDA Inspections of Device Establishments - Guidance for Industry and Food and Drug Administration Staff Press Release: Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection FAQs on Diagnostic Testing for SARS-CoV-2 (Updated) Federal Register: Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments