EUAs

Emergency Use Authorization (EUA) is a regulatory mechanism that allows the use of unapproved medical products or unapproved uses to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency. In the United States, EUAs are issued by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. An EUA may be issued when the Secretary of Health and Human Services declares an emergency, there is reasonable belief that the product may be effective, the known and potential benefits outweigh the risks, there are no adequate approved alternatives, and the emergency requires such use.

EUA provisions typically require labeling and information for health professionals and patients about the EUA status, risks, limitations, and recommended use. They may specify distribution, conditions for use, and surveillance obligations, including adverse event reporting and data collection. An EUA is not a full FDA approval; it is temporary and contingent on ongoing evidence. It can be modified, revoked, or terminated as more data become available or as the emergency ends. If and when sufficient evidence accumulates, a product may move from EUA to full approval or market authorization.

EUAs may apply to vaccines, therapeutics, diagnostic tests, or medical devices. They were widely used during the COVID-19 pandemic to provide access to vaccines, therapies, and tests before formal approvals were in place. Beyond the United States, other jurisdictions have similar mechanisms, but the terminology and requirements differ.