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On January 31, 2020, in response to the COVID-19 pandemic, the Secretary of Health and Human Services (HHS) issued a declaration of a public health emergency (PHE) under Section...
The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related...
On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in...