In-vitro diagnostics (IVDs) in times of crisis: what manufacturers, labs and clinicians need to know

Why this matters

When a public health emergency strikes—such as the emergence of a novel pathogen—the speed with which diagnostic tests become available can literally save lives. But fast does not mean without oversight. The Food and Drug Administration (FDA) plays a critical role in ensuring that IVDs are reliable even in emergencies.

In recent years, especially during the COVID19 pandemic, diagnostic tests authorized under emergency pathways became central. In response, the FDA has now published a finalized guidance on how it will handle IVDs in emergencies going forward. Regulatory Affairs Professionals Society

This blog breaks down:

The legal and regulatory framework for emergency IVD use
Key recent guidance and what it says
What stakeholders (manufacturers, labs, health systems) should know and do
Some practical implications and “look-out” considerations

Legal & regulatory framework

EUA authority and IVDs

The basis for emergency use of medical products, including IVDs, is the Emergency Use Authorization (EUA) under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Emergency Use Authorization of Medical Products and Related Authorities

Key elements:

The Secretary of U.S. Department of Health and Human Services (HHS) must make a determination that circumstances exist justifying authorization. Emergency Use Authorization
The FDA may authorize the emergency use of an unapproved medical product or an unapproved use of an approved product when certain criteria are met: serious or life-threatening disease/condition, no adequate approved alternatives, and the known and potential benefits outweigh the risks.
For IVDs specifically, this means tests that have not yet undergone full regulatory review may be authorized for emergency use. For example, the COVID-19 IVDs. In Vitro Diagnostics EUAs

Enforcement discretion vs EUA

Not all tests can go through a full EUA immediately. The FDA also uses enforcement discretion policies: during an emergency the agency may permit certain unapproved diagnostics to be marketed under specific conditions (rather than full EUA) while the crisis persists. The recent guidance clarifies how that will work for IVDs.

What happens when the emergency ends?

Important to note: the EUA declaration (under Section 564) is separate from a Public Health Emergency (PHE) declared under Section 319 of the Public Health Service Act. The EUA declaration generally continues until terminated by HHS. What happens to EUAs when a public health emergency ends?
When the declaration ends, ongoing EUAs may end, and diagnostics must transition to traditional regulatory pathways (e.g., 510(k), PMA) or be withdrawn. COVID-19 Emergency Use Authorizations for Medical Devices

‍New FDA Guidance: What’s Changed

In September 2025, FDA finalized new guidance titled “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency”.

Let’s highlight the major take-aways:

Key assessment factors

When determining whether to issue an enforcement policy (or authorization) for IVDs in an emergency, FDA will consider four main factors:

Public health need – How urgent is the situation? How many people are at risk? What is the potential impact?
Benefits and risks – Does the potential benefit of deploying a new IVD outweigh the risks (such as false positives/negatives)?
Availability of alternatives – Are there already approved or authorized IVDs available that can meet the need? If yes, the threshold for authorizing a new test may be higher.
Mitigations – Are there measures to reduce risk (e.g., validation studies, confirmatory testing, and clear labeling)?

Formalizing enforcement discretion

Previously, many emergency diagnostics were authorized in a somewhat ad hoc way. With this guidance, FDA is setting out a permanent framework for how it will use enforcement discretion for IVDs in future emergencies.

Validation expectations

For IVDs during a crisis, the FDA released draft guidance (January 2024) on how to validate tests for emerging pathogens (e.g., limit of detection, inclusivity, clinical performance). While a draft at the time, it's an important reference.

Key elements include:

Analytical validation: limit of detection (LoD), inclusivity/reactivity, cross-reactivity, interfering substances.
Clinical performance: sample types, specimen selection, human subject protections.
Templates provided by FDA to help streamline submissions.

Transition plans and ending enforcement policies

When the emergency ends or sufficient approved tests become available, diagnostic authorizations under enforcement discretion must transition to full marketing authorization or be withdrawn. COVID-19 Emergency Use Authorizations for Medical Devices

Why this update matters

The guidance responds to a recommendation from the U.S. Government Accountability Office (GAO) that the FDA develop a permanent policy for diagnostics in emergencies.
It offers greater clarity for test developers, labs, and regulators about how emergency diagnostics will be handled in future outbreaks.
It may accelerate deployment of diagnostics during emergencies, while maintaining safeguards against unreliable tests.

‍What manufacturers, labs & health systems should keep in mind

For manufacturers / test developers

Early planning for emergencies pays off. Consider establishing contingency protocols for rapid validation (LoD, inclusivity, specimen types) so you can pivot in a crisis.
Documentation: Even under enforcement discretion, robust validation is expected. Keep detailed analytical and clinical data.
Labeling & communications: You’ll need clear Risk/Benefit statements, intended use, alternatives, and disclaimers around test limitations.
Supply chain and scale planning: Public health need is a key factor—if you cannot supply broadly, FDA may focus on tests with high-throughput or scalable manufacturing.
Post-market monitoring: Even during emergency use, you’ll need to monitor performance, report adverse events or issues, and plan for transition to full marketing.

For clinical laboratories & health systems

Know the status of any IVDs you use: Is it EUA-authorized, enforcement-discretion, or fully cleared/approved?
Understand test limitations: Especially in an emergency scenario, false negatives/positives carry larger public-health implications. Labs need to communicate with clinicians about how to interpret results.
Operational readiness: Be ready to switch between tests as emergency policies terminate or transition.
Diagnostic stewardship: Use diagnostics appropriately, so you’re supporting public health decisions, avoiding misuse of tests that may have higher uncertainty.

For regulators & public-health stakeholders

Balance speed with reliability: The new guidance aims to help regulators permit faster deployment of diagnostics while still ensuring they meet performance expectations.
Transparency: Clear criteria and communication about when enforcement discretion applies and when it ends helps maintain trust.
Resilience: Having validated pathways in place before a crisis makes the system more responsive—this guidance is a step toward that.

Practical implications & pitfalls

Emerging pathogens: The guidance will likely apply to future outbreaks (viruses, bacteria, even non-infectious threats) where diagnostics are needed rapidly.
False results = real harm: The company emphasizes that false negatives or positives can undermine outbreak control, mislead public health responses, and erode public trust.
Transitioning is key: Even if you obtain emergency use, you should plan how you will move to full authorization or withdrawal when the emergency ends. Tests cannot remain in limbo indefinitaly.
Labelling changes: In emergencies, you might see tests with more limited claims (e.g., “for use under EUA during Section 564 emergency”)—users must understand what those claims mean.
Regulatory uncertainty remains: Although the guidance formalizes many things, each emergency is unique. FDA retains flexibility to tailor its approach to the context.
Global implications: U.S. FDA policy often influences diagnostics regulation elsewhere. Manufacturers serving international markets should monitor how other regulators align with or diverge from these standards.

Sample timeline & “how to” in a nutshell

Emergency declared under Section 564 (HHS Secretary determination + declaration).
Manufacturer/developer prepares validation studies (LoD, inclusivity, clinical performance) following FDA templates/draft guidance.
Developer submits EUA request or works with FDA on an enforcement-discretion policy depending on circumstances (availability of alternatives, urgency, etc.).
Upon authorization or policy issuance, tests are deployed under specified conditions (labeling, performance monitoring, reporting).
Post-emergency: transition to full marketing authorization, or termination of EUA/enforcement policy; labs and users adapt accordingly.

Final thoughts

The newly finalized FDA guidance on emergency use of IVDs marks an important evolution: it transforms what was a largely reactive, expedition-driven process during COVID-19 into a more structured, transparent framework for future crises.

For diagnostics companies, labs, and health systems, the message is clear: speed matters—but so does reliability, documentation, clarity, and planning. Getting tests out fast is essential—but so is ensuring that they deliver trustworthy results, because in a crisis they become tools not just for individual patients, but for public-health strategy.

#FDA #IVD #EmergencyUseAuthorization #MedTech #RegulatoryAffairs #PublicHealthPreparedness #DiagnosticInnovation

Source: Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff

🧩 FDA Emergency Use IVD Readiness Checklist

1. Pre-Emergency Preparedness

Goal: Be ready to mobilize quickly and meet FDA expectations when an emergency declaration occurs.

✅ Regulatory & Quality Systems

Maintain an established Quality Management System (QMS) compliant with 21 CFR 820 or ISO 13485.
Ensure clear design controls and documented change management processes.
Keep templates for EUA submission and validation summaries up to date.
Identify internal or partner contacts for regulatory affairs, validation, and communications.

✅ Validation & Technical Readiness

Develop and document rapid analytical validation protocols (e.g., LoD, inclusivity, cross-reactivity, interfering substances).
Maintain reference materials, control panels, and specimen libraries for emerging pathogens.
Validate instrument platforms and sample handling procedures for adaptability.
Establish risk assessment templates to weigh benefits vs. risks during emergencies.

✅ Supply Chain & Operations

Identify critical suppliers and second sources for reagents and consumables.
Maintain scalable manufacturing plans to meet surge demand.
Map out logistics partners for distribution during restricted travel or emergencies.

✅ Communications & Training

Prepare crisis communication templates (for FDA, customers, and public updates).
Train teams on EUA requirements, labeling needs, and post-market reporting.
Keep contact lists for FDA’s CDRH Office of In Vitro Diagnostics and industry trade groups.

2. During an Emergency Declaration

Goal: Rapidly deploy and authorize safe, effective diagnostic solutions.

✅ Regulatory Pathway

Confirm an official Section 564 declaration by HHS and the disease/condition covered.
Determine whether your test qualifies for EUA or enforcement discretion.
Engage with FDA early — pre-EUA submission meeting if possible.
Prepare and submit:
Analytical validation data
Clinical performance data
Manufacturing and quality documentation
Labeling and instructions for use
Risk/benefit justification

✅ Labeling & Instructions

Include “For use under FDA Emergency Use Authorization” (or equivalent) statement.
Clearly outline intended use, specimen types, and limitations.
Add warnings about false results and appropriate confirmatory testing.

✅ Post-Market Monitoring

Implement systems to track test performance and field complaints.
Report any adverse events or performance issues to FDA promptly.
Maintain version control for any updates to procedures or reagents.

✅ Communication & Coordination

Update laboratories, distributors, and clinicians on authorized test versions.
Align messaging with CDC and public-health agencies.
Document all communications with FDA for audit readiness.

3. Post-Emergency Transition

Goal: Transition from emergency use to long-term regulatory compliance or market withdrawal.

✅ Regulatory Transition Planning

Track when EUA or enforcement discretion will end.
Prepare to submit 510(k), De Novo, or PMA application if continuing to market.
Conduct gap analysis between EUA documentation and full submission requirements.
Update labeling and promotional materials to remove emergency-use references.

✅ Product Lifecycle & Quality

Continue post-market surveillance until product status is finalized.
Validate any modifications made during the emergency under standard controls.
Archive all EUA communications, submissions, and performance data.

✅ Lessons Learned

Conduct internal after-action review of response effectiveness.
Update SOPs and emergency playbooks based on findings.
Document best practices and challenges for future emergency readiness.

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