FDA Finalizes Guidance on Emergency Use of IVDs During Public Health Crises (2025)

On 22 September 2025, the U.S. Food and Drug Administration (FDA) issued its finalized guidance outlining how it will authorize the emergency use of in vitro diagnostic tests (IVDs) during future public health emergencies. The guidance provides a permanent framework for exercising enforcement discretion under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and replaces the earlier draft guidance released in May 2024.

Why This Guidance Matters

This final guidance comes in response to recommendations from the U.S. Government Accountability Office (GAO) in 2022, which urged the FDA to establish a permanent policy for handling diagnostic test approvals in emergencies.

For manufacturers, laboratories, and healthcare providers, the guidance offers long-awaited clarity on:

• How the FDA will evaluate unapproved or unauthorized IVDs during an emergency.

• Criteria used for enforcement discretion, including benefit-risk balance, availability of alternatives, and the urgency of public health needs.

• Expectations for managing false results, which could impact both patient care and broader public health decisions.

Key Points from the Final Guidance

Authorization Under FD&C Act Section 564

The FDA may authorize emergency use of unapproved medical products or unapproved uses of approved products when the Secretary of Health and Human Services (HHS) declares a relevant emergency involving chemical, biological, radiological, or nuclear (CBRN) threats, or other agents posing heightened risks (including those affecting U.S. military forces).

Factors Considered by FDA

The agency will weigh several factors before authorizing IVDs:

• Public health need – urgency and scale of the emergency.

• Benefit-risk assessment – potential patient benefits vs. risks of inaccurate results.

• Availability of alternatives – presence of FDA-approved or authorized IVDs.

• Risk mitigation – whether measures are in place to reduce false negatives or false positives.

Importance of Risk Management

FDA emphasized that false results not only endanger individual patients but can also misguide critical public health decisions during emergencies, such as outbreak containment strategies.

Impact on IVD Manufacturers and Laboratories

The guidance is particularly relevant for IVD manufacturers, test developers, and clinical laboratories that may seek rapid authorization of new diagnostics in the next health crisis.

• Regulatory clarity: A defined pathway for temporary use of unapproved diagnostics.

• Faster market entry: Potential to deploy innovative IVDs more quickly when time is critical.

• Compliance expectations: Companies must implement strong quality systems to minimize inaccurate results and demonstrate risk mitigation strategies.

Related resource: FDA Medical device / IVD Registration Pathway

Next Steps for Stakeholders

• Monitor FDA guidance: Stay up to date with updates to EUA and IVD regulatory requirements.

• Prepare documentation early: Manufacturers should have pre-validated data packages ready for rapid submission.

• Engage with FDA: Consider pre-submission meetings to clarify expectations before emergencies arise.

• Strengthen quality management systems: Robust design controls and validation procedures are essential.

Official Resources

• FDA Final Guidance on Emergency Use of IVDs (2025)

• FDA – Emergency Use Authorization (EUA) for Medical Devices

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