Original from: The U.S. Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) today announced that Secretary Robert F. Kennedy, Jr. has signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs and biological products and for medical devices, concluding that the circumstances that justified these emergency authorities no longer exist.
“Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,” said HHS Secretary Robert F. Kennedy, Jr. “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 following advance notice periods to ensure an orderly transition. The declaration for drugs and biological products will terminate 12 months after the Secretary’s determination, while the declarations for medical devices will terminate 180 days after the Secretary’s determination.
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.
The advance notice periods are designed to provide 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 will publish notices of the terminations in the Federal Register and provide the notifications required by law to Congress.
Source: HHS Secretary Kennedy Signs COVID-19 Emergency Use Authorization Declaration Terminations
