CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New August 27, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 26, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Advanta Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation) QDX SARS-CoV-2 Assay (QDx Pathology Services) Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Biocan Diagnostics Inc.) BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.) Updated Emergency Use Authorizations Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases) (EUA Summary, Revision) FAQs on Testing for SARS-CoV-2 (Updated) Webinar Reminder - Regulatory Overview for Developers and Sponsors of Neurological and Physical Medicine Devices: An Introduction to the De Novo Pathway - August 27, 2020