CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New July 8, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 7, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Laboratorio Clinico Toledo SARS-CoV-2 Assay Assure COVID-19 IgG/IgM Rapid Test Device (Assure Tech. - Hangzhou Co., Ltd) Updated Emergency Use Authorizations LetsGetChecked Coronavirus (COVID-19) Test (PrivaPath Diagnostics, Inc.) - Letter Granting EUA Amendment(s) (July 6, 2020) Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Respirator Models Removed from Appendix A (Respirator Models No Longer Authorized) CLEWICU System - Letter Granting EUA Amendment(s) (June 30, 2020) FAQs on Testing for SARS-CoV-2 (Updated)