U.S. Food and Drug Administration (FDA): Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Coronavirus disease 2019 (COVID-19) emergency use authorizations (EUAs) for medical devices in healthcare refer to the process by which the US Food and Drug Administration (FDA) may allow the use of certain medical devices to diagnose, treat, or prevent COVID-19 in emergency situations, prior to the completion of the usual regulatory review and approval process. EUAs for medical devices in the context of COVID-19 may be issued when there are no satisfactory alternative treatments available, and the potential benefits of using the device outweigh the potential risks. EUAs for medical devices may be issued for a specific period of time, and may be revised or terminated as new information becomes available. Examples of medical devices that have received EUAs for use in the context of COVID-19 include diagnostic tests, personal protective equipment (PPE), and respiratory support devices. Overall, the use of EUAs for medical devices in the context of COVID-19 is an important tool for allowing healthcare providers to access and use necessary medical devices in emergency situations, while ensuring that the risks and benefits of these devices are carefully evaluated.