CDRH New - March 20, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 19, 2020. To view listings for other dates, see CDRH New - News and Updates.

Emergency Use Authorizations - Added ePlex SARS-CoV-2 Test (GenMark Diagnostics, Inc.) and Simplexa COVID-19 Direct (DiaSorin Molecular LLC) MQSA Inspection Information Related to COVID-19 POSTPONED: Public Workshop - Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond - March 31, 2020