CDRH New - April 23, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 22, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: IntelliVue Patient Monitors (Philips Medizin Systeme Boeblingen GmbH) altona Diagnostics GmbH (RealStar SARS-CoV-2 RT-PCR Kit U.S) Diatherix Eurofins Laboratory (SARS-CoV-2 PCR Test) FAQs on Ventilators Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190025 added)