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    FDA guidances for medical device regulation after enforcement discretion and EUA expiration

    This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires. These policies may evolve as the US Food and Drug Administration (FDA) awaits declaration from the secretary of Health and Human Services (HHS) stating that the pandemic has ended. The author suggests this limited oversight of the manufacture of ...