Demystifying the Use-Related Risk Analysis (URRA)

White Paper + Companion FAQ

Published by Carson Whitaker, Associate Director, Interface Analysis Associates LLC (IAA),
and Anthony Andre, PhD, CPE, Director and Founder, IAA

Understanding the Role of the URRA in Medical Device Development

The Use-Related Risk Analysis (URRA) is one of the most important, and often misunderstood, components of a human factors engineering program. While regulatory expectations surrounding human factors and usability continue to evolve, many organizations still struggle to determine how the URRA should be developed, maintained, and incorporated into overall risk management activities.

This white paper explores the purpose of the URRA, common misconceptions surrounding its use, and practical considerations for integrating URRA activities into a human factors validation strategy.

Whether your team is preparing for a regulatory submission or refining an existing human factors process, understanding the role of the URRA can help support more effective risk analysis and decision-making.

What You’ll Learn

• The purpose and role of the URRA within human factors validation programs
• How the URRA differs from traditional risk management tools and analyses
• Common misconceptions and FDA feedback related to URRA development and submissions
• How the URRA supports risk identification, critical task analysis, and validation planning
• Practical strategies for developing a URRA that aligns with FDA expectations

Download the Resources

White Paper

Demystifying the Use-Related Risk Analysis (URRA) in Human Factors Validation Programs

Explore the purpose of the URRA, common misconceptions, and practical considerations for incorporating URRA activities into a human factors validation strategy.

Companion FAQ

Frequently Asked Questions About URRAs

Get quick answers to common questions about use-related risk analyses, their role in human factors engineering, and how they support risk management and validation activities.

Have questions about URRAs or human factors validation? Contact Interface Analysis Associates to discuss your unique development and regulatory needs.