Editor's Pick
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...