HHS moved to end COVID-era Emergency Use Authorization (EUA) declarations for medical devices starting a 180-day countdown, with similar terminations for drugs and biologics beginning 12 months from now. The agency said the transition is meant to reinforce that emergency authorities are temporary and that manufacturers and healthcare systems have had time to adapt to standard FDA pathways. An HHS analysis highlighted the scale of EUA testing issued between 2020 and 2023, including 373 EUAs for in vitro diagnostics. HHS also cited modeling in Clinical and Translational Science and Lancet Public Health to frame the earlier public health impact while noting the regulatory landscape has changed substantially. For biotech and diagnostics players, the shift increases the importance of maintaining evidence packages, quality systems, and post-market readiness under non-EUA frameworks, particularly for product renewals and label strategies that rely on conventional authorization routes.