FDA Emergency Use Authorization (EUA) is a temporary pathway that lets unapproved medical products reach US patients during a declared public health emergency. It is not a substitute for 510(k) clearance or PMA approval, it is not permanent, and the EU has no direct equivalent — MDR instead allows Member State derogations under Article 59.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • EUA is a crisis pathway authorised by the FDA under sections of the Federal Food, Drug, and Cosmetic Act following a declaration of emergency by the Secretary of HHS.
  • The evidence bar is lower than 510(k) or PMA but not absent — "may be effective" and a favourable risk-benefit under the emergency circumstances.
  • EUA is temporary. When the emergency declaration ends, EUA ends. Products must transition to a permanent pathway (510(k), De Novo, or PMA) or come off the market.
  • The EU has no direct equivalent under MDR. Article 59 of Regulation (EU) 2017/745 instead allows individual Member States to grant derogations permitting specific devices on their national market in the interest of public health.
  • COVID-era EUAs taught the industry expensive lessons about planning for the post-emergency transition from day one, not at the last minute.
  • For EU MedTech startups, EUA is a narrow tool. Most of you will never use it directly. Understanding it matters mainly for US market timing, crisis response readiness, and investor conversations.

Why this matters

In early 2020 a wave of European MedTech startups watched US competitors ship ventilators, diagnostics, and PPE into the American market in weeks rather than years. Some of them misread what was happening. They thought the FDA had "relaxed the rules" and that a similar window was open in Europe. It was not.

What was happening was EUA — Emergency Use Authorization — a specific, narrowly scoped FDA mechanism that only operates during a declared public health emergency. It is not a lighter version of 510(k). It is not a regulatory loophole you can ask for because your device is "important." It is a tool the FDA uses when it judges, on a specific emergency declaration, that the risk-benefit calculus of letting unapproved products through has flipped.

For EU founders, three things matter about EUA: what it actually is, what the COVID era actually taught us about it, and why MDR has no direct equivalent. That last point decides a lot of transatlantic strategy conversations.

What FDA law actually says

EUA sits in the US Federal Food, Drug, and Cosmetic Act . It is triggered by a declaration from the Secretary of Health and Human Services that an emergency or threat justifies the emergency use of medical products. Once that declaration is in place, FDA can authorise unapproved products — or unapproved uses of approved products — to be used to diagnose, treat, or prevent the threat.

The statutory criteria, in plain language, are:

  1. The agent in question can cause a serious or life-threatening condition.
  2. Based on the totality of scientific evidence available, it is reasonable to believe the product may be effective.
  3. The known and potential benefits outweigh the known and potential risks, considering the threat.
  4. There is no adequate, approved, and available alternative.

"May be effective" is the important phrase. It is a lower standard than "substantial equivalence" (the 510(k) bar) or "reasonable assurance of safety and effectiveness" (the PMA bar). It is not "no evidence required." FDA still expects analytical validation, clinical validation where relevant, labelling, performance data, and post-authorisation monitoring.

EUA is not permanent. When the underlying emergency declaration is terminated, the EUA terminates with it, subject to a transition period FDA publishes for each specific product category.

The EU has no direct equivalent. Regulation (EU) 2017/745 addresses a similar public health need through Article 59 — "Derogation from the conformity assessment procedures." Under Article 59, individual Member State competent authorities may, on a duly justified request, authorise the placing on the market of a specific device for which the normal conformity assessment procedures have not been carried out, when the use of that device is in the interest of public health or patient safety or health. This is a national act, not a pan-European one, and during COVID the European Commission used the mechanism by inviting Member States to coordinate derogations. The key point: there is no EU-wide emergency pathway. There are 27 national pathways under MDR Article 59.

A worked example

A Berlin diagnostics startup develops a rapid antigen test for a novel respiratory virus during a declared public health emergency in early 2028. Their board asks: "Can we ship to the US under EUA and to the EU under the same kind of fast track?"

US side. If HHS has declared an emergency and FDA has opened an EUA pathway for respiratory diagnostics, the company can submit an EUA request with analytical performance data, a limited clinical validation study, labelling including a Fact Sheet for Healthcare Providers, and a post-authorisation commitment. Decision in weeks, not months. The company can ship once authorised.

EU side. There is no single European equivalent. Their options are:

  • Complete normal MDR conformity assessment. Too slow for the crisis.
  • Apply for an Article 59 derogation in each Member State where they want to sell. Germany via BfArM, France via ANSM, Austria via BASG, and so on. Each authority decides independently. Each approval is national. Each has its own evidence expectations.
  • Wait for the European Commission to recommend coordinated derogations across Member States, as happened during COVID-19.

The company will move fastest in the US. In the EU they will need a national-by-national strategy. Both pathways are temporary. Both require planning for the permanent route — 510(k) or De Novo in the US, full MDR certification in the EU — from day one. The startups that forgot that during 2020 and 2021 are the ones that ended up off the market when the emergencies ended.

The Subtract to Ship playbook

For most EU MedTech startups, EUA is a second-order concern. Here is how to think about it without overinvesting.

1. Do not build a business model that depends on EUA. EUA exists to meet specific emergencies. It is not a route to market. If your pitch deck assumes EUA-enabled US entry, your business model has a fatal dependency on a declaration that may never come, or may end at the worst possible moment. Build the plan for permanent clearance — 510(k), De Novo, or PMA — and treat EUA as optional acceleration, not as foundation.

2. If you are in an emergency-relevant category, plan the transition from day one. The most expensive COVID-era lesson: startups that shipped under EUA and did not start their permanent 510(k) work in parallel ran out of runway when the emergency ended. The moment FDA authorises under EUA, start the clock on substantial equivalence work, predicate selection, and the regulatory file for a real 510(k) or De Novo. The transition is not automatic. The data you need for the permanent pathway is different from the data you needed for the EUA.

3. Understand MDR Article 59 as a parallel but different tool. An Article 59 derogation under MDR is a national permission for a specific device. It does not give you a CE certificate. It does not substitute for a notified body. It does not convert into a permanent MDR clearance. When the derogation ends, the normal conformity assessment applies, and you need to have been running it in parallel.

4. For dual EU-US strategies, separate the crisis pathway from the commercial pathway. Treat EUA and MDR Article 59 as tactical access tools. Treat 510(k)/De Novo/PMA and MDR conformity assessment as the strategic commercial pathways. Your regulatory plan needs both rows on the spreadsheet, with separate milestones, separate budgets, and separate evidence packages.

5. Get the US agent and FDA electronic submission infrastructure in place early. If you might ever submit an EUA request, you need an FDA account, a US agent of record, and an understanding of the eSubmitter templates. Setting this up during a real emergency is too late.

6. Keep honest about the risk-benefit framing. EUA and Article 59 both rest on "the emergency makes the risk-benefit favourable." They do not excuse sloppy engineering. A device that fails basic safety testing will not be authorised just because there is a crisis. The 2020 EUA withdrawals on several COVID antigen tests are the reference case. Quality still matters. Always.

Reality Check

Use these questions to decide whether EUA or Article 59 belongs in your regulatory strategy at all.

  1. Is your device intended for a condition that could plausibly be the subject of a public health emergency declaration?
  2. If yes, have you mapped which FDA pathway (510(k), De Novo, or PMA) you would need for permanent clearance after an EUA?
  3. For the EU, have you identified which Member States you would approach for Article 59 derogations and what their national evidence expectations look like?
  4. Does your regulatory budget assume permanent clearance as the baseline and emergency access as optional acceleration — not the other way around?
  5. Do you have an FDA account, US agent, and submission infrastructure in place before you might need them?
  6. Have you separated EUA/Article 59 timelines from your commercial clearance timelines on your regulatory roadmap?
  7. Can you describe to an investor, in one sentence, what happens to your business when an emergency declaration ends?

Frequently Asked Questions

Is EUA still active after COVID-19? Some COVID-related EUAs have been terminated, others have been transitioned or extended during the wind-down period published by FDA. Other public health emergencies have their own EUA authorisations independent of COVID. The framework itself remains active and can be triggered for future emergencies.

Does CE marking help me get an FDA EUA? CE marking is not equivalent to FDA clearance and does not by itself satisfy EUA criteria. FDA may consider existing international data and certifications as part of the scientific evidence, but EUA decisions are US-specific and depend on US emergency declarations.

Can I sell in the EU under an Article 59 derogation without a CE mark? Yes, but only in the Member State that granted the derogation, only for the device and scope specified in the derogation, and only during the period the derogation is in force. It is not a CE mark and does not allow free movement across the EU single market.

Does EUA or Article 59 exempt me from quality management system requirements? No. FDA still expects appropriate quality controls, labelling, and post-market monitoring. MDR Article 59 does not waive the general safety and performance requirements — it waives the conformity assessment procedure, which is a narrower concept.

What happens to EUA products when the emergency ends? FDA publishes a transition plan for each product category. Manufacturers must either obtain a permanent marketing authorisation (510(k), De Novo, or PMA) during the transition period or remove the product from the US market.

Should a seed-stage EU startup spend time understanding EUA? Not in depth. Know that it exists, know that it is temporary, know that it is not the same as MDR Article 59, and know that it is not a substitute for normal market authorisation on either side of the Atlantic. That is enough until the topic actually becomes relevant to your device and your market.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 59 (Derogation from the conformity assessment procedures).
  2. FDA Emergency Use Authorization framework — Federal Food, Drug, and Cosmetic Act .
  3. FDA guidance "Emergency Use Authorization of Medical Products and Related Authorities" — current version on fda.gov.
  4. European Commission communications on MDR Article 59 coordinated derogations during the COVID-19 public health emergency.