CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New August 12, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 11, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Solaris Multiplex SARS-CoV-2 Assay (Solaris Diagnostics) Alpha Genomix TaqPath SARS-CoV-2 Combo Assay (Alpha Genomix Laboratories) Prismaflex HF20 Set (Baxter Healthcare Corporation) Updated Emergency Use Authorizations Smart Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.) Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China FAQs on Testing for SARS-CoV-2 (Updated) FDA In Brief: FDA Posts Additional Postmarket Information for Essure Problems Reported with Essure ESSURE Medical Device Reporting Variance Spreadsheet - June 2020 Consumer Information on: WATCHMAN Left Atrial Appendage Closure Device with Delivery System and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System – P130013/S035 Registration and Listing of Medical Devices during the COVID-19 Pandemic Importing Medical Devices During the COVID-19 Pandemic