FDA Emergency Use Authorization (EUA) for Medical Devices: Complete Regulatory Pathway Guide

The EUA Pathway Exists Outside Normal FDA Review — Here Is How It Works

The Emergency Use Authorization (EUA) authority under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) allows the FDA to authorize unapproved medical products — or unapproved uses of approved products — during declared emergencies involving chemical, biological, radiological, or nuclear (CBRN) threats. It is a fundamentally different pathway from 510(k), PMA, or De Novo, with its own legal basis, evidentiary standards, and termination mechanics.

During the COVID-19 pandemic alone, the FDA issued hundreds of EUAs for diagnostic tests, ventilators, personal protective equipment, and other devices. But the EUA framework predates COVID-19 — it was created after the September 11 attacks and the 2001 anthrax incidents through the Project BioShield Act of 2004, and was subsequently amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013.

This guide covers the complete EUA pathway for medical devices: the legal prerequisites, the step-by-step process, the four statutory criteria, how EUA compares to traditional marketing pathways, and what happens when an EUA declaration is terminated.

Legal Basis and Legislative History

Section 564 of the FD&C Act

The EUA authority is codified at Section 564 of the FD&C Act (21 U.S.C. § 360bbb-3). It was originally enacted through the Project BioShield Act of 2004, which was itself a response to the recognition that existing regulatory frameworks — including Investigational Device Exemptions (IDEs) and expanded access programs — were too slow and administratively burdensome for large-scale emergency response.

Key amendments include:

The January 2017 Final Guidance

The FDA finalized its comprehensive guidance document "Emergency Use Authorization of Medical Products and Related Authorities" in January 2017. This guidance remains the primary interpretive document for the EUA process. It describes the criteria for issuance, the types of determinations and declarations that trigger EUA authority, conditions the FDA may impose, and the process for termination.

How an EUA Is Triggered: Declarations and Determinations

Before the FDA can issue any EUA, two things must happen in sequence: a determination of a threat, and a declaration by the HHS Secretary.

Step 1: Threat Determination

One of four types of determinations must be made:

Step 2: HHS Secretary Declaration

Based on one of these determinations, the Secretary of HHS issues a declaration under Section 564(b)(1) that circumstances exist justifying the authorization of emergency use of specific product categories (e.g., in vitro diagnostics, personal protective equipment, ventilators, drugs, biological products).

The declaration specifies:

• The CBRN agent or agents involved
• The categories of products covered
• The period during which EUAs may be issued
• Any limitations on the scope of authorization

Step 3: Pre-EUA Engagement

Sponsors can engage with the FDA through pre-EUA activities before formally submitting an EUA request. This includes preliminary data sharing, discussion of the intended use, and alignment on the evidence package needed. The FDA typically coordinates closely with HHS, CDC, and other federal partners throughout this process.

Step 4: EUA Request Submission

A formal EUA request should not be submitted until the HHS Secretary has issued the applicable Section 564(b)(1) declaration. The request includes:

• Device description and intended use
• Manufacturing information
• Safety and effectiveness data
• Risk-benefit analysis
• Proposed labeling (including Fact Sheets for healthcare providers and patients)
• Conditions of use
• Any available alternatives analysis

Step 5: FDA Review and Authorization

The FDA reviews the EUA request against the four statutory criteria (see below). If the criteria are met, the FDA issues an EUA letter specifying:

• The authorized product and its intended use
• Conditions the manufacturer must meet (e.g., adverse event reporting, recordkeeping, labeling requirements)
• Fact Sheets for healthcare providers and patients
• The scope of the authorization (who may use it, where, under what circumstances)

Step 6: Duration and Termination

An EUA remains in effect for the duration of the applicable Section 564 declaration. The HHS Secretary must provide advance notice in the Federal Register before terminating a declaration. Once terminated, the EUA is no longer valid.

The Four Statutory Criteria for EUA Issuance

Under Section 564(c) of the FD&C Act, the FDA must determine that four criteria are satisfied before issuing an EUA:

Criterion 1: Serious or Life-Threatening Disease or Condition

The CBRN agent referenced in the HHS Secretary's declaration must be capable of causing a serious or life-threatening disease or condition. This is typically established through the underlying determination and declaration rather than argued by the sponsor.

Criterion 2: Evidence of Effectiveness ("May Be Effective")

The product "may be effective" in diagnosing, treating, or preventing the disease or condition. Critically, the standard here is lower than the effectiveness standard required for formal approval or clearance. The FDA assesses potential effectiveness on a case-by-case basis using a risk-benefit analysis based on the totality of scientific evidence available.

For devices, this may include:

• Bench testing and performance data
• Prior marketing history in other countries
• Data from similar or predicate devices
• Limited clinical data if available
• In silico or modeling data

Criterion 3: Risk-Benefit Analysis

The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, must outweigh the known and potential risks. The FDA must also take into consideration the material threat posed by the CBRN agent(s).

Criterion 4: No Adequate, Approved, and Available Alternatives

There must be no adequate, approved, and available alternative to the product. "Available" means both legally marketed and sufficient in supply. This criterion ensures that EUAs are issued only when needed — if a cleared or approved device already addresses the emergency need, a new EUA is unnecessary.

EUA vs Traditional FDA Pathways: Key Differences

Conditions the FDA May Impose on EUAs

Under Section 564(e), the FDA may impose various conditions on EUA holders, including:

For Manufacturers

• Distribution recordkeeping (lot identification, shipping records, facility addresses)
• Adverse event reporting requirements
• labeling requirements, including Fact Sheets
• Manufacturing under current good manufacturing practices (to the extent practicable)
• Post-authorization data collection
• Periodic reporting to the FDA

For Healthcare Facilities and Providers

• Reporting requirements for adverse events
• Conditions on who may use the device
• Patient notification requirements
• Training or certification requirements

For Distributors

• Recordkeeping on distribution
• Notification requirements
• Conditions on dispensing

EUA Transition to Permanent Marketing Authorization

The Post-COVID Framework

When a Section 564 declaration is terminated, all EUAs issued under that declaration expire. The FDA recognized that manufacturers would need time to transition from EUA-based marketing to traditional pathways. In March 2023, the FDA finalized two transition guidance documents:

1. Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) — addresses devices authorized under EUAs
2. Transition Plan for Medical Devices That Were Subject to Enforcement Policies Related to Coronavirus Disease 2019 (COVID-19) — addresses devices marketed under enforcement discretion

Transition Process for EUA Devices

The transition framework works as follows:

Key transition requirements include:

• Submitting the marketing application before the EUA termination date
• Updating device labeling to note it was previously authorized under EUA and is now under review
• Complying with full Quality Management System Regulation (QMSR) requirements, including design controls that may not have been fully implemented under the EUA
• Addressing any gaps between EUA-level evidence and the standard required for the target pathway

Practical Challenges in Transition

Manufacturers transitioning from EUA to permanent authorization commonly face:

• Design control gaps: EUA products may not have gone through the full design control process required by QMSR (21 CFR 820)
• Clinical evidence gaps: The "may be effective" standard is lower than what is needed for 510(k), De Novo, or PMA
• Manufacturing compliance: Full cGMP/QMSR compliance may require process validation updates
• Labeling overhauls: Replacing Fact Sheets with standard device labeling per 21 CFR Part 801

Historical EUA Activity for Medical Devices

Pre-COVID EUAs (2004-2019)

Before COVID-19, the FDA issued EUAs primarily for infectious disease diagnostics and countermeasures:

COVID-19 EUAs (2020-2023)

The COVID-19 pandemic represented the largest-scale use of the EUA authority in history. Key categories included:

• In vitro diagnostics: Over 400 EUAs for molecular, antigen, and serology tests
• Personal protective equipment: N95 respirators, surgical masks, face shields
• Ventilators and respiratory support devices: Full ventilators, ventilator accessories, and alternative products
• Remote monitoring devices: Pulse oximeters, digital thermometers
• Digital health products: Software for remote patient monitoring

Active EUAs as of 2026

As of 2026, most COVID-19 device EUAs have transitioned or expired following the termination of the COVID-19 Section 564 declarations. The most recent Section 564 declaration was issued on August 18, 2025 for New World Screwworm (NWS) — notably, the EUAs under this declaration are for animal drugs, not medical devices, illustrating the broad scope of the EUA authority beyond human medical products.

Preparing an EUA Request: Practical Considerations

When to Engage the FDA

Sponsors should engage with the FDA as early as possible through the pre-EUA process. This is especially important because:

• EUA timelines are compressed — the FDA may need to authorize products within days
• The evidence package must be tailored to the specific emergency context
• Conditions of authorization should be discussed proactively
• Coordination with other federal agencies (CDC, BARDA, DoD) may be necessary

Building the Evidence Package

Even though the evidentiary standard is "may be effective," sponsors should aim to provide the strongest evidence package possible:

1. Device description: Detailed technical specifications, intended use, mechanism of action
2. Performance data: Bench testing, analytical validation (for IVDs), engineering verification
3. Prior evidence: Data from other jurisdictions, published literature, prior submissions
4. Risk analysis: Comprehensive risk assessment identifying known and potential risks
5. Benefit analysis: How the product addresses an unmet need in the emergency context
6. Alternatives analysis: Why existing products are inadequate or insufficient
7. Manufacturing: Description of manufacturing processes, quality controls, and capacity
8. Labeling: Proposed Fact Sheets and instructions for use

Common Pitfalls

FAQ

What is the difference between an EUA and an FDA clearance or approval?

An EUA is a temporary authorization that permits the emergency use of an unapproved product or an unapproved use of an approved product during a declared emergency. It uses a lower evidentiary standard ("may be effective") compared to the standards for 510(k) clearance (substantial equivalence) or PMA approval (reasonable assurance of safety and effectiveness). EUAs expire when the underlying Section 564 declaration is terminated.

Can a device that received an EUA continue to be marketed after the emergency ends?

Not automatically. Once the Section 564 declaration is terminated, the EUA expires. The manufacturer must obtain a traditional marketing authorization (510(k) clearance, De Novo classification, or PMA approval) to continue distributing the device. The FDA's transition guidance provides a 180-day enforcement discretion period if a marketing application has been accepted for review before the EUA termination date.

Who can request an EUA?

Any manufacturer or sponsor of a medical product may request an EUA. In practice, requests are often coordinated with federal agencies such as CDC, BARDA, or DoD. The FDA also works closely with the Assistant Secretary for Preparedness and Response (ASPR) at HHS.

Does an EUA require clinical trials?

No. The EUA standard is "may be effective," which is lower than the effectiveness standard for formal approval. While clinical data strengthens an EUA request, it is not required. The FDA evaluates the totality of available scientific evidence, which may include bench testing, analytical validation, prior marketing history, and published literature.

What is the difference between an EUA and an Investigational Device Exemption (IDE)?

An IDE permits the investigational use of a device in a clinical study to collect safety and effectiveness data. An EUA authorizes emergency use outside the clinical trial context, without requiring informed consent or IRB approval. EUAs are for emergency situations; IDEs are for research.

How long does EUA review take?

EUA review timelines vary significantly based on the urgency of the emergency and the completeness of the submission. During COVID-19, some EUAs were issued within days. Pre-EUA engagement with the FDA can accelerate the formal review process.

Can a device with an EUA be used off-label?

No. EUA authorization specifies the exact intended use, user population, and conditions of use. Use outside the authorized scope would not be covered by the EUA. However, the FDA may authorize multiple intended uses under a single EUA or issue amendments to expand the scope.

What happens to adverse event reporting under an EUA?

The EUA authorization letter specifies adverse event reporting requirements. These typically include mandatory reporting of serious adverse events and may include additional reporting conditions beyond standard Medical Device Reporting (MDR) under 21 CFR Part 803. The specific requirements vary by EUA.

Are EUAs only for pandemics?

No. The EUA authority covers any emergency involving CBRN agents, including bioterrorism, chemical spills, radiation events, and emerging infectious diseases. The 2025 New World Screwworm EUA is an example of a non-pandemic use.

Can the FDA revoke an EUA?

Yes. The FDA may revoke an EUA if the criteria for issuance are no longer met — for example, if an adequate approved alternative becomes available, or if new information shows that the risks outweigh the benefits. Revocation is separate from termination of the underlying Section 564 declaration.