While FDA reviewers and European notified bodies share the same goal of ensuring medical devices can be used safely and effectively, their approaches to evaluating usability evidence differ. Valentina Lintas, Regulatory Affairs and Quality Manager at Veranex, explores these differences and shares practical insights on building stronger usability strategies that support regulatory success across both markets.
Key Takeaways:
- Different Approaches, Shared Objectives: FDA reviewers emphasize the severity of potential harm when identifying critical tasks, while European notified bodies focus heavily on alignment with risk management principles. Despite these differences, both expect credible evidence demonstrating safe and effective device use.
- Building Stronger Usability Evidence: Regulatory reviewers look beyond test results to evaluate how critical tasks were identified, whether participants represent intended users, and how findings connect to risk management. Clear traceability between usability activities, identified risks, and regulatory conclusions is essential.
- Planning for Regulatory Success Early: Integrating human factors and regulatory expertise early in development helps manufacturers anticipate reviewer expectations, identify potential evidence gaps, and avoid costly rework during submission preparation.
- Usability Is More Than a Test: Usability should inform decisions throughout the product lifecycle, not simply serve as a final regulatory checkpoint. Strong submissions demonstrate safe and effective device use through clear, connected evidence rather than relying on study size alone.