CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New August 20, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 19, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.) Updated Emergency Use Authorizations ePlex SARS-CoV-2 Test (GenMark Diagnostics, Inc.) Appendix A: Authorized Surgical Masks Appendix B: Authorized Ventilators Webinar - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway - August 27, 2020 UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus Ultraviolet (UV) Radiation (Updated) FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated) Federal Register: Medical Devices; Reports of Corrections and Removals Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee