CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New August 19, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 18, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations COVID-19 Nucleic Acid RT-PCR Test Kit (ZhuHai Sinochips Bioscience Co., Ltd.) BioCheck SARS-CoV-2 IgG and IgM Combo Test (BioCheck, Inc.) Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit (Diazyme Laboratories, Inc.) Public Workshop - Orthopedic Device-Related Infections - November 13, 2020 Considerations for Selecting Respirators for Your Health Care Facility Manufacturing and Distributing Respirators for Health Care Use in the United States Under an Existing Emergency Use Authorization (EUA) During the COVID-19 Pandemic FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic (Updated) Consumer Information on: The Arctic Front Advance™ and Arctic Front Advance Pro™ and The Freezor Max™ Cardiac Cryoablation Catheters - P100010/S098 Archived Webcast and Presentations added to Public Workshop - Spinal Device Premarket Review - August 13, 2020 FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated)