USA – US FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview

The US Food and Drug Administration (FDA) has 26 active guidance documents related to special recommendations for medical devices during the COVID-19-associated public health emergency. Medical device types covered include personal protective equipment (gloves, masks, etc.), certain remote assessment and monitoring devices, ventilators, sterilizers, disinfectants, infusion pumps, thermometers and telethermographic systems, digital health devices for treating psychiatric disorders, and diagnostic tests for COVID-19.

The EUA route is intended to provide an expedited route to the US market for devices that could help address the public health emergency. The FDA has not published specific timeframe expectations for these applications, and in Emergo’s experience, the time to authorization is highly variable, and has generally increased with the duration of the public health emergency.