Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization

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*Update as of March 8, 2023:**The Biden Administration has[stated its intention](https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf)to end the public health and national emergency declarations related to the COVID-19 pandemic on May 11, 2023. However, this determinationdoes notalter the status of medical devices that have been temporarily approved for use under Emergency Use Authorizations (EUAs). As things currently stand, EUA devices may continue to be used beyond that date. For further information, see our article[Emergency Use Authorization for Medical Devices Has Not Been Terminated](/search-results/member-preview/hdjournal/pages/euas-for-medical-devices-not-terminated). *

To meet the unprecedented need for medical equipment and supplies during the COVID-19 public health emergency (C19PHE), FDA has temporarily authorized the use of hundreds of medical devices that had not previously been approved for use. Through its Emergency Use Authorization authority, FDA can designate previously unapproved products—or previously unapproved uses of approved products—as acceptable for use during an emergency (United States Code U.S.C. 21 U.S.C. § 360bbb-3a).

While EUA devices can be deployed to meet emergency...