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

Let's Talk Risk! Podcast · Jun 19, 2026 · 41m

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…