Lexology May 5, 2023
By Squire Patton Boggs

On March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products subject to one of these pathways should review the agency guidance if they wish to continue marketing the products. If an entity is not sure whether an EUA applies to a product, FDA has generated a full list at this site.

On January 31, 2020, the Department of Health and Human Services (HHS) first determined a public health emergency (PHE) existed because of COVID-19. This...

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Topics: FDA, Govt Agencies, Healthcare System, Medical Devices, Public Health / COVID
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