Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions

Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions

From Let's Talk Risk! with Dr. Naveen Agarwal by Casual and informal conversations about practical aspects of medical device risk management.

June 19, 2026 · 41 min

About this episode

This episode discusses the implications of the FDA's new human factors guidance on medical device submissions and risk management.

You cannot reverse engineer your human factors regulatory strategy at the 11th hour. FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about use-related risk, critical tasks, labeling, training, post-market evidence, and design change control across the product lifecycle. In this audio case study, we walk through why Category 3 human factors validation may become the default concern when critical tasks are introduced or impacted and why Decision Point D is not a shortcut, but an evidence-based exception that depends on history of use, user interface complexity, and the adequacy of existing risk controls. Key highlights covered in the audio: * Why human factors can no longer be treated as a late-stage submission activity * How use-related risk analysis drives the identification of critical tasks * Why Category 3 validation may be triggered by more than obvious design changes * How Decision Point D may reduce submission burden — but only with strong evidence * Why post-market surveillance data now has direct pre-market strategic value Keywords: FDA human factors guidance, medical device marketing…

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