CDRH New - April 13, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 10-12, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: Face Shields STERIS Sterilization Systems for Decontamination of N95 Respirators CytoSorbent, Inc. Extracorporeal Blood Purification (EBP) Device iAMP COVID-19 Detection Kit (Atila BioSystems, Inc.) Orig3n 2019 Novel Coronavirus (COVID-19) Test (Orig3n, Inc.) ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit (Rutgers Clinical Genomics Laboratory-Rutgers University) SDI SARS-CoV-2 Assay (Specialty Diagnostic (SDI) Laboratories) UNC Health SARS-CoV-2 real-time RT-PCR test Advanced Sterilization Products (ASP) STERRAD Sterilization System Updated Emergency Use Authorizations: Xpert Xpress SARS-CoV-2 test - Letter Granting EUA Amendment(s) (April 8, 2020) Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)