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From Emergency Use Authorization to 510(k) Clearance: Preparing Physician Offices for the December 2026 Transition
For physician offices that perform respiratory testing, December 26, 2026 is more than a date on the calendar. It is the day the federal declarations supporting emergency use authorization (EUA) of certain COVID-19 medical devices, including in vitro diagnostic tests used to detect or diagnose SARS-CoV-2, are scheduled to terminate.3 On June 29, 2026, the U.S. Department of Health and Human Services (HHS) Secretary determined that circumstances no longer exist to justify those declarations, and...
Point Of Care Testing
