The URRA is becoming even more important
By Horacio M Pace-Bedetti, PhD, Principal Human Factors Engineer
Question this answers
Why is the URRA central to FDA human factors medical device submissions?
The Use-Related Risk Analysis sits at the centre of determining what human factors information the FDA requires. It identifies critical tasks, evaluates modifications, and assesses risk control effectiveness. Regulators view it as a living document that must be continuously updated with user feedback and post-market data rather than treated as a static submission checklist.
One thing that became very clear to me during the recent FDA town hall is that the URRA is going to matter even more under the new submission framework.
Not because the URRA is new. It has been a foundational part of human factors and risk management for years. But now it sits directly at the center of the decision about what Human Factors information FDA needs to see. That means your URRA is expected to do a lot more heavy lifting.
Are there critical tasks? Has a modification introduced new ones or changed the old ones? Are the existing risk controls still working the way you think they do? What evidence actually supports those conclusions? You cannot answer these questions with a URRA that was created before validation, updated for the submission, and then forgotten. That approach isn’t enough anymore.
FDA continues to describe the URRA as a living document. I think companies need to start treating it like one. Update it when the product changes. Connect it to real user feedback and post-market data. Use it to drive ongoing risk management, not just to check off a regulatory requirement.
Because under this framework, a good URRA is part of the evidence behind your regulatory strategy and the main thread tying your risk analysis, design controls, and human factors work together. If you get it right, it can make the entire submission process smoother and faster.
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