Emergency Use Authorizations | FDA

Emergency Use Authorizations | FDA

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

New Emergency Use Authorizations Applied DNA Sciences, Inc. One Health Laboratories, LLC Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine Infusion Pumps and Infusion Pump Accessories Updated Emergency Use Authorizations Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories Roche Molecular Systems, Inc (RMS) Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190031 added and DEN180065 updated) FAQs on Testing for SARS-CoV-2 (Updated) FDA News Release: FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients Federal Register: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff