Regulatory
Emergency Use Authorization(EUA)
In one line
FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies.
Definition
Emergency Use Authorization (EUA) is FDA authority under FD&C Act section 564 to authorize an unapproved medical product or unapproved use of an approved product after an applicable section 564(b) declaration and satisfaction of the statutory criteria. An EUA is not FDA clearance or approval. It remains effective until the applicable section 564 declaration terminates or FDA revokes the authorization; it is not automatically ended by expiration of a PHSA public health emergency. Product-specific conditions govern labeling, information for providers and recipients, reporting, and records.
Why it matters
Plan for the applicable EUA termination and FDA transition policy rather than assuming a universal transition window. As of November 1, 2026, FDA reports that COVID-19 device EUA declarations will terminate December 26, 2026, and the drug and biologic declaration June 29, 2027. Review individual authorizations and transition policies, including any continued-use provisions for already distributed products.
Common pitfalls
- •Treating EUA as approval, labeling, marketing, and reimbursement implications differ significantly from cleared/approved status.
- •Assuming the end of a PHSA emergency automatically ends an EUA, or assuming all products receive the same transition period.
- •Failing to follow adverse-event reporting conditions in the individual EUA, which may differ from ordinary requirements.
Sources
- Emergency Use Authorization · FDA
- EUA of Medical Products Guidance · FDA
- European Commission - Medical Devices · European Commission