Volume 13, Number 7—July 2007
Policy Review
Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, United States
Table
Actions required before issuance of an EUA*
| Step | Required action | Responsible authority |
|---|---|---|
| 1 | Determination of an emergency justifying issuance of an EUA | Secretary of Homeland Security OR Secretary of Defense OR Secretary of Health and Human Services |
| 2 | Declaration of emergency | Secretary of Health and Human Services |
| 3 | Consultation (to the extent feasible) between the FDA, NIH, and CDC | FDA commissioner, NIH director, CDC director |
| 4 | Issuance of an EUA | FDA commissioner (under delegated authority from Secretary of Health and Human Services) |
*EUA, Emergency Use Authorization; FDA, US Food and Drug Administration; NIH, National Institutes of Health; CDC, Centers for Disease Control and Prevention.
