CDRH New - April 6, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 3-5, 2020. To view listings for other dates, see CDRH New - News and Updates.

Emergency Use Authorizations - Added SARS-Cov-2 Assay (Diagnostic Molecular Laboratory - Northwestern Medicine), SARS-CoV-2 RT-PCR test (Infectious Disease Diagnostics Laboratory - Children’s Hospital of Philadelphia), Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (Co-Diagnostics, Inc.), ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (ScienCell Research Laboratories), ARIES SARS-CoV-2 Assay (Luminex Corporation), and MGH COVID-19 qPCR assay (Massachusetts General Hospital). Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic (Updated) FAQs on Shortages of Surgical Masks and Gowns (Updated) N95 Respirators and Surgical Masks (Face Masks) (Updated) Medical Devices and the COVID-19 (Coronavirus) Pandemic (Updated) Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers (Updated) Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19 Updated Letter to Industry on COVID-19 - April 4, 2020 Webinar - Enforcement Policy for Personal Protective Equipment (PPE) During COVID-19: Immediately in Effect Guidance - April 6, 2020 Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories (Appendix B Updated) FAQs on Diagnostic Testing for SARS-CoV-2 (Updated) Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180030 added)