Initially posted on FDA.gov — On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. Also see PREP Act declaration: Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020).
On the basis of the February 4, 2020 HHS EUA determination, the Secretary of HHS then declared on March 24, 2020, that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 pandemic, subject to the terms of any authorization issued under that section, authorizing the emergency use of 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 that FDA determines meet the criteria for safety, performance and labeling set forth in Section II and Appendix A for emergency use in healthcare settings to treat patients during the COVID-19 pandemic, contingent upon submission of a request from the sponsor of a ventilator, ventilator tubing connector, or ventilator accessory as described in Section II and pursuant to the Conditions of Authorization in Section IV of this letter.
Manufacturers and other stakeholders may submit a request to FDA at in order to have their products added to the EUA.
Date EUA Issued
Ventilators (Letter of Authorization)
Fact Sheet for Healthcare Providers
Fact Sheet for Patients
|03/24/2020||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||Healthcare Providers||Patients||Appendix A|
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