Case Study
Let's Talk Risk! Podcast
Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions
- Published
- June 19, 2026
- Duration
- 41:26
- Summary source
- description
- Last updated
- Jul 5, 2026
Discusses You cannot reverse engineer your human factors regulatory strategy at the 11th hour.FDA’s new human …
Summary
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…
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Show notes
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