Emergency Use Authorization (EUA)
The Emergency Use Authorization (EUA) authority under FD&C Act § 564 [21 U.S.C. § 360bbb-3] allows FDA to authorise the use of unapproved medical products — or unapproved uses of approved products — during declared public health emergencies.
Statutory basis
FD&C Act § 564 requires four conditions:
- The Secretary of HHS has declared a public health emergency, or a military or domestic emergency involving a heightened risk of attack
- There is evidence suggesting the product may be effective to prevent, diagnose, or treat the disease or condition
- The known and potential benefits of the product, when used to diagnose, prevent, or treat the disease, outweigh the known and potential risks
- There is no adequate, approved alternative available
Who can use an EUA device?
EUA medical devices can be used only:
- In accordance with the conditions of authorization (specific patient population, healthcare setting, labelling requirements)
- During the declared emergency
- Under the required labelling — EUA devices must bear the statement that the product has not been approved but has been authorized for emergency use
The EUA process
- Emergency declaration — HHS Secretary declares the emergency
- EUA request — Manufacturer (or FDA itself, for government-held products) submits request to CDRH/CBER
- FDA review — FDA reviews available data under the § 564 "may be effective" standard (lower than "substantial equivalence" or "reasonable assurance")
- EUA issued — FDA issues an EUA letter with conditions of authorization
- Post-authorization — FDA may revoke the EUA if conditions change; manufacturer must submit required reports
COVID-19 EUAs — notable examples
The COVID-19 Public Health Emergency (Jan 2020 – May 2023) resulted in hundreds of device EUAs:
| Device type | Examples |
|---|---|
| Molecular diagnostic tests | PCR-based SARS-CoV-2 tests |
| Antigen tests | Rapid antigen tests for home and POC use |
| Serology tests | Antibody tests for prior infection |
| PPE | N95 respirators under Emergency Use Authorization |
| Ventilators | Certain non-FDA-cleared ventilators |
| Infusion pumps | For treatment of COVID-19 patients |
EUA vs clearance/approval
| Feature | EUA | 510(k) Clearance | PMA Approval |
|---|---|---|---|
| Standard | May be effective | Substantially equivalent | Valid scientific evidence |
| Duration | During declared emergency | Permanent (until device changes) | Permanent (with supplements) |
| Revocable? | Yes, if conditions change | No (unless safety issue) | No (unless safety issue) |
| Requires emergency? | Yes | No | No |
| Post-emergency status | EUA terminates; must seek clearance/approval | Continues | Continues |
After the emergency ends
When an emergency declaration terminates:
- EUAs for devices automatically terminate unless FDA takes affirmative action to keep them in place
- Manufacturers who wish to continue marketing must seek 510(k) clearance or PMA approval
- FDA typically provides a transition period and guidance on the pathway