USA: FDA announces emergency use authorizations for ventilators due to COVID-19 outbreak

The Food and Drug Administration (FDA) announced the enactment of emergency use authorizations (EUAs) on the basis of the February 4, 2020 Human Health Service determination (HHS). The HHS determination justified the emergency use of medical devices, such as ventilators, to treat patients during the COVID-19 outbreak because of its significant potential to affect the health and security of US citizens.

The devices under the EUA must meet the criterion for labels, safety and performance set forth for emergency use in healthcare settings.

This EUA covers ventilators, anaesthesia gas machines modified as ventilators, ventilator tubing connectors as well as ventilator accessories.

For a manufacturer to have their products added to the EUA list, a request must be submitted to the FDA.

For more detailed information, visit the FDA’s website here.

How TSG can help

TSG’s consultants have been keeping track of the most recent policy modifications from the FDA during this public health emergency. We can determine the best regulatory strategy to address the data requirements for FDA’s review, as well as develop and review data claims and labelling of ventilators to comply with FDA regulations.