CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New May 29, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 28, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorization PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus (COVID-19) Test Updated Emergency Use Authorization Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR eMDR System Enhancements Class I Recall: Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up FAQs on Testing for SARS-CoV-2 (Updated)