Amid Concerns of Shortage, FDA Issues Emergency Use Authorization for Ventilators,...

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  1. cafead

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    via You’ve seen the news about insufficient supply and availability of ventilators to treat patients with Coronavirus Disease 2019 (COVID-19). You’ve also likely seen news of ideas to mitigate this shortage. 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. Eligible devices include “ventilators, ventilator tubing connectors and ventilator accessories that are not currently marketed in the U.S., or that are currently marketed in the U.S., but a modification is made to the device that would trigger the requirement that a manufacture submit a new premarket notification (510(k)) to FDA.” Policy at 3.

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