The U.S. Food and Drug Administration (FDA) has issued a guidance authorizing the emergency use of 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 that FDA determines meet the criteria for certain safety, performance, and labeling criteria in healthcare settings to treat patients during the COVID-19 pandemic.
Authorized uses in these emergency conditions are 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 the Letter of Authorization found at the “Ventilators EUA” section of the FDA’s Emergency Use Authorizations (EUAs) website.
Manufacturers and other stakeholders may submit a request to FDA in order to have their products added to the EUA. For more information, e-mail CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.
Edited by Michael Causey