CDRH New - May 14, 2020

CDRH New May 14, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 13, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Abbott Molecular Inc. Columbia University Laboratory of Personalized Genomic Medicine Updated Emergency Use Authorizations Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories Molecular Diagnostic Template for Manufacturers Molecular Diagnostic Template for Laboratories Presentation and Transcript added to: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - May 6, 2020 Virtual Town Hall - 3D Printed Swabs - May 15, 2020 FAQs on Testing for SARS-CoV-2 (Updated) Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras) Consumer Information on: TREO® Abdominal Stent-Graft System - P190015 EUA Authorized Serology Test Performance (Updated) Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adverse Event Program for Medical Devices (Medical Product Safety Network)