FDA Issues Emergency Use Authorization for Ventilators

The FDA issued an Emergency Use Authorization (EUA) for certain 510(k) cleared ventilator devices in response to the COVID-19 outbreak.

The authorization allows some ventilators, anesthesia gas machines and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories, to be used in healthcare settings for emergency treatment of patients during the pandemic.

To be cleared for emergency use, the devices must be deemed effective in treating patients during the outbreak and have no sufficient approved alternatives. They also must meet safety, performance and labeling criteria laid out by the agency.