HHS Phasing Out COVID-19 Emergency Use Authorizations

The U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) program is nearing the end of its run.

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. recently signed determinations terminating COVID-19 EUA declarations for drugs and biological products and for medical devices. He decided to end the EUAs after concluding the circumstances that justified these authoritizations no longer exist.

“Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,” Kennedy said. “By ending these COVID-19 emergency use authorization declarations, we’re reinforcing public confidence that emergency authorities are temporary and targeted.”

The terminations will take effect after advance notice periods to ensure an orderly transition. The declaration for drugs and biological products will end on June 29, 2027, while the declarations for medical devices will end on Dec. 26 (2026).

The COVID-19 EUA declarations were first issued in 2020 to enable rapid access to medical products during the pandemic. Since then, the public health landscape has changed substantially. FDA-approved, cleared, and licensed products are now widely available through traditional regulatory pathways, reliance on EUA products has declined, and manufacturers have had years to prepare for a transition from emergency authorities, according to the HHS.

The advance notice periods are designed to give manufacturers, healthcare providers, health systems, distributors, and patients adequate time to transition away from products authorized solely under the COVID-19 EUA declarations. During this transition, HHS and the Food and Drug Administration (FDA) will continue working with manufacturers on appropriate regulatory pathways for products seeking traditional approval, clearance, or licensure.

HHS is publishing notices of the terminations in the Federal Register and providing the notifications required by law to U.S. Congress.