Amid Concerns of Shortage, FDA Issues Emergency Use Authorization for Ventilators, Accessories and Other Respiratory Devices

On March 24, 2020 FDA issued an Emergency Use Authorizations (EUA) 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 (EUA) and a companion policy, Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Policy) to allow emergency use of ventilators in healthcare settings.