For a product to receive an EUA, it must meet specific criteria, including:
Serious or Life-Threatening Disease: The product must address a serious or life-threatening condition. Evidence of Effectiveness: There must be evidence that the product may be effective in diagnosing, treating, or preventing the disease. Risk-Benefit Analysis: The known and potential benefits of the product must outweigh the known and potential risks. No Alternatives: There must be no adequate, approved, and available alternatives.
