CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New July 20, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 17-18, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Boston Heart COVID-19 RT-PCR Test (Boston Heart Diagnostics) xMAP SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation) Updated Emergency Use Authorizations Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Appendix B: Authorized Ventilator Accessories Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.) Third Party Performance Report - FY20, Q3 Class I Recall: Verathon, Inc. Recalls GlideScope Core One TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use FAQs on Testing for SARS-CoV-2 (Updated) FDA News Release: Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing