An EUA can be issued by regulatory bodies like the U.S. Food and Drug Administration (FDA) when certain statutory criteria are met. These criteria generally include:
A determination that the agent involved in the emergency can cause serious or life-threatening diseases or conditions. Evidence that the product may be effective in diagnosing, treating, or preventing the disease or condition. A risk-benefit analysis showing that the known and potential benefits of the product outweigh the known and potential risks. No adequate, approved, and available alternatives.
