Continuing developments and Strategies for Human Factors approval in the U.S. and EU

Written By Science Designer

by Dr. David Grosse-Wentrup

An Ever-changing Landscape

Bringing medical devices and combination products to market is complex, especially when targeting both the U.S. and EU, where regulatory requirements differ. Moreover, both U.S. and EU are currently facing different challenges and developments.

With the Medical Devices Regulation (MDR) taking effect in the EU 2021, medical device manufacturers faced stricter requirements for safety, performance, and clinical evidence compared to the old Medical Device Directive. As this led to elevated regulatory burden and cost, as well as prolonged time to market, the European Parliament has recently adopted a resolution to update the MDR and In Vitro Diagnostics Regulation [1], with feedback and consultation period recently being completed [2].

Meanwhile, the U.S. still sees the effects of a reduction in staff [3, 4] that is affecting the entire FDA, including the Center for Drug Evaluation and Research (CDER) and it’s siter department, the Center for Biologics Evaluation and Research (CBER) [4]. While the full effects of these staffing changes are yet to be seen, we are closely monitoring the impact on timelines for FDA submissions as well as pre-submission meetings.

Routes to Approval

In addition to the need to adapt to these changing situations, companies and Human Factors teams have always been faced with differing regulatory requirements between the U.S. and EU.

Therefore, manufacturers generally pursued one of three approval strategies: EU-first, U.S.-first, or parallel. The best path depends on factors such as company location, budget, and timelines.

A simultaneous HFE approach can reduce costs and time to market by allowing one validation study and aligned reports to serve both authorities. However, certain differences regarding Human Factors need to be considered.

In the U.S., FDA regulation 21 CFR 820.30 [5] and guidance documents such as Applying Human Factors and Usability Engineering to Medical Devices [6] define expectations for usability engineering in submissions. In the EU, manufacturers follow IEC 62366-1:2015 [7] and it’s 2020 amendment [8] to show compliance with MDR’s safety and performance requirements. Both systems treat usability engineering as part of risk management, but they differ across key areas: document portfolio, structure, content, terminology, and study location.

Document portfolio: The FDA expects a single Human Factors /Usability Engineering Report, while IEC standards allow more flexibility with multiple documents.

Document structure: The FDA provides a clear expected structure; IEC standards specify content but not format.

Content differences: The FDA requires a conclusion up front on device safety and effectiveness, while IEC standards are less specific in most sections.

Terminology: Terminology and definitions differ between FDA guidance and IEC 62366. Although both documents address similar concepts, they often use different terms (e.g., FDA’s “validation” vs. IEC’s “summative”) or apply different definitions to the same terms (e.g., “use error,” “close call,” “use difficulty”). Another prominent example is the difference between critical tasks in the FDA guidances and hazard related use scenarios in IEC 62366. These discrepancies impact how user performance is assessed and reported for usability studies.

Study location: The FDA requires validation studies to be conducted in the U.S., while IEC technically imposes no geographic restrictions. Thus, a U.S. study can meet both sets of requirements and reduce costs significantly.

Staying One Step Ahead

In general, Human Factors teams should tailor strategy by region. U.S. companies are best served by performing all studies domestically with combined U.S./EU documentation. EU companies may conduct formative studies locally to save costs, but should plan final validation in the U.S. For some cases, running summative studies in the EU and validation in the U.S. may speed approval.

Especially in the current situation, monitoring regulatory changes and observing early warning indicators such as feedback times for FDA pre-submissions can be critical to adjust the strategy to market early on to shorten time to market and costs, making global commercialization more efficient.

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