CORRECTED - Ventilators: FDA Issues Emergency Use Authorization

FDA Issues Emergency Use Authorization for Ventilators

Yesterday, the U.S. Food and Drug Administration (FDA) took action to make more ventilators available to health care personnel in the United States. The FDA issued an emergency use authorization for 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. Yesterday’s emergency use authorization allows ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories to be used in health care settings during the coronavirus (COVID-19) pandemic. Manufacturers and other stakeholders may submit a request to the FDA under the process outlined in the EUA to have their device(s) added to the EUA.

Learn More Questions? If you have questions about the EUA, email CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.