CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New August 17, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 14-15, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases) Updated Emergency Use Authorizations Personal Protective Equipment EUAs GenePro SARS-CoV-2 Test (Gencurix, Inc.) Platelia SARS-CoV-2 Total Ab assay (Bio-Rad Laboratories, Inc.) LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin Inc.) Intersurgical StarMed CaStar R Hood for NIV (Intersurgical, Inc) Medical Device Accessory Classification Request Granting Decisions FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated) Medical Device Shortages During the COVID-19 Public Health Emergency FDA News Release: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing Federal Register: Physical Medicine Devices: Reclassification of Non-Invasive Bone Growth Stimulators