CDRH New - March 13, 2020

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

Emergency Use Authorizations - Added cobas SARS-CoV-2 (Roche Molecular Systems, Inc.) Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee Updated: FAQs on Diagnostic Testing for SARS-CoV-2 Consumer Information on: AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) (Model DFT015), AcrySof™ IQ Vivity™ Toric Extended Vision IOLs (DFT315, DFT415, DFT515), AcrySof™ IQ Vivity™ Extended Vision UV Absorbing IOL (DAT015), and AcrySof™ IQ Vivity™ Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) - P930014/S126