The transition period allows manufacturers and healthcare providers time to shift toward traditional regulatory pathways for medical products.
RT’s Three Key Takeaways:
- Emergency Authority Termination: HHS secretary Robert F Kennedy, Jr signed determinations to end COVID-19 emergency use authorizations for drugs, biological products, and medical devices because the emergency circumstances no longer exist.
- Orderly Transition Periods: The termination for medical devices will take effect in 180 days, while the declaration for drugs and biological products will conclude in 12 months to allow for a managed transition.
- Regulatory Path Alignment: Healthcare providers and manufacturers are encouraged to transition toward products with traditional Food and Drug Administration approval, clearance, or licensure, as reliance on emergency authorized products has declined.
The US Department of Health and Human Services (HHS) announced that secretary Robert F Kennedy, Jr has signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs, biological products, and medical devices, according to the agency. The department concluded that the circumstances justifying these emergency authorities are no longer present.
“Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,” said Robert F Kennedy, Jr, HHS secretary. “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 intended to ensure an orderly transition for the industry. 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 determination.
The COVID-19 EUA declarations were first issued in 2020 to enable rapid access to medical products during the pandemic. Since that time, the public health landscape has changed significantly. Food and Drug Administration (FDA) approved, cleared, and licensed products are now widely available through traditional regulatory pathways, and manufacturers have had several years to prepare for a transition from emergency authorities, according to the news release.
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 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.
Image: Sarah Stierch (CC BY 4.0)
