CDRH New - March 23, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 20-22, 2020. To view listings for other dates, see CDRH New - News and Updates.

Emergency Use Authorizations - Added Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd) Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff News Release: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - March 25, 2020 FAQs on Shortages of Medical Gloves Medical Glove Conservation Strategies: Letter to Health Care Providers FAQs on Diagnostic Testing for SARS-CoV-2 (Updated) Emergency Use Authorizations - Added Xpert Xpress SARS-CoV-2 test (Cepheid) Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff Ventilator Supply Mitigation Strategies - Letter to Health Care Providers