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April 02, 2020

FDA Issues Emergency Use Authorizations in Response to COVID-19

Over the past week, the FDA has issued a series of Emergency Use Authorizations (EUA) to allow providers to better respond to the current public health emergency. Using an EUA, the FDA can approve the use of unapproved medical products or unapproved uses of approved medical products when there are no adequate alternatives. The most recent COVID-19-related EUAs have focused on ventilators and personal protective equipment (PPE).

The Ventilator EUA allows certain devices, such as anesthesia gas machines and positive pressure breathing devices, to be modified for use as ventilators. Some individual ventilators are also being authorized under the EUA to be used to support multiple patients. One of the PPE EUAs allows for decontamination of N-95 respirators. Another allows for the use of respirators that are not approved by the National Institutes of Occupational Safety and Health, but are instead approved using the standards of other countries allowing for greater ability to import PPE. EUAs continue to be assessed and updated as the needs of providers and patients evolve.