What obligations does a manufacturer take on once a device receives EUA authorization?

EUA holders must comply with FDA-imposed conditions including specific labeling requirements, providing Fact Sheets for Healthcare Providers and for patients or recipients, adverse event reporting, recordkeeping, and any additional conditions FDA specifies in the individual authorization, and these obligations continue for as long as the EUA remains in effect.

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Emergency Use Authorization

FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

Definition

Emergency Use Authorization (EUA) is FDA authority under FD&C Act section 564 to authorize an unapproved medical product or unapproved use of an approved product after an applicable section 564(b) declaration and satisfaction of the statutory criteria. An EUA is not FDA clearance or approval. It remains effective until the applicable section 564 declaration terminates or FDA revokes the authorization; it is not automatically ended by expiration of a PHSA public health emergency. Product-specific conditions govern labeling, information for providers and recipients, reporting, and records.

What the regulation says

FDA may issue an EUA under FD&C Act section 564 after the HHS Secretary issues a declaration under section 564(b), based on an applicable statutory determination. FDA must find a serious or life-threatening disease or condition, reasonable belief that the product may be effective, that known and potential benefits outweigh known and potential risks, and no adequate, approved, available alternative. A PHSA section 319 emergency alone is not sufficient, and its expiration does not automatically terminate an EUA declaration.

What this means in practice

Plan for the applicable EUA termination and FDA transition policy rather than assuming a universal transition window. As of November 1, 2026, FDA reports that COVID-19 device EUA declarations will terminate December 26, 2026, and the drug and biologic declaration June 29, 2027. Review individual authorizations and transition policies, including any continued-use provisions for already distributed products.

Examples

Illustrative: During a novel respiratory virus pandemic, a diagnostic test manufacturer received an EUA to rapidly distribute its test kit, enabling widespread screening before full marketing authorization could be obtained.
Illustrative: Following a chemical attack, the FDA issued an EUA for an unapproved therapeutic drug, allowing healthcare providers to administer it to affected individuals when no approved treatments were available.
Illustrative: A manufacturer of personal protective equipment (PPE) secured an EUA for its N95 respirators, permitting their distribution and use by healthcare workers during a severe public health emergency where standard supply chains were overwhelmed.

Common pitfalls

•Treating EUA as approval, labeling, marketing, and reimbursement implications differ significantly from cleared/approved status.
•Assuming the end of a PHSA emergency automatically ends an EUA, or assuming all products receive the same transition period.
•Failing to follow adverse-event reporting conditions in the individual EUA, which may differ from ordinary requirements.

Frequently asked questions

An EUA is not FDA clearance or approval. It remains effective until the applicable section 564 declaration terminates or FDA revokes the authorization; it is not automatically ended by expiration of a PHSA public health emergency. Product-specific conditions govern labeling, information for providers and recipients, reporting, and records.

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Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Official-source claim check: 2026-11-01

Section 564 authorization is distinct from marketing approval and requires a section 564(b) declaration plus statutory issuance criteria, not merely a PHSA public health emergency.

Partial review: verified corrections are applied, but this is not a full accuracy certification. The last full review date is unchanged.

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Original merged record reviewed in full. Illustrative examples are hypothetical, not verified case histories. Evidence supports the specific propositions below, not an assertion that every linked page verifies all merged content.

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Link health: 3 verified· last checked 2026-06-20

FDA·2European Commission·1

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Category: Regulatory
Acronym: EUA
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Updated: 6/20/2026

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Learn in 60 seconds

FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies.

·Plan for the applicable EUA termination and FDA transition policy rather than assuming a universal transition window.
·As of November 1, 2026, FDA reports that COVID-19 device EUA declarations will terminate December 26, 2026, and the drug and biologic declaration June 29, 2027.
·Review individual authorizations and transition policies, including any continued-use provisions for already distributed products.

Remember this

Watch out: Treating EUA as approval, labeling, marketing, and reimbursement implications differ significantly from cleared/approved status.

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