FDA

The PREP Act and Liability for EUA Medical Equipment

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During the COVID-19 Pandemic, in order to address shortages of crucial medical equipment such as face masks and ventilators, the Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) to allow certain manufacturers to make medical equipment who do not normally do so. Any manufacturer who produced this medical equipment under an EUA was given immunity from product liability under the Public Readiness and Emergency Preparedness (PREP) Act.

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