Morgan Lewis May 10, 2023
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of Health and Human Services (HHS) on January 31, 2020, and subsequently renewed several times, provided the basis for numerous flexibilities upon which the healthcare and life sciences industries have relied to furnish patient care during the pandemic. With the PHE coming to an end, organizations may need to make drastic changes as the regulatory enforcement returns to “normal.”
For example, the US Food and Drug Administration (FDA) granted emergency use authorizations to certain medical (particularly COVID-19 testing) devices to support the nation’s response...
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