In March 2020, the US Secretary of Health declared that circumstances exist justifying the authorization of emergency use of certain personal protective equipment (PPE) during the COVID-19 outbreak, subject to the terms of any authorization issued under that section.

The Emergency Use Authorization allows FDA to help strengthen the nation’s public health protections against certain threats by facilitating the availability and use of resources needed during public health emergencies. As the result, FDA has established an expedited approval process for certain PPE products for overseas manufacturers and suppliers.  

Posted in FAQ