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

Page: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/case-study-fda-s-new-expectation-for-use-related-risk-in-medical-device-submissions
Text version: https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844/case-study-fda-s-new-expectation-for-use-related-risk-in-medical-device-submissions.md
Podcast: [Let's Talk Risk! Podcast](https://stenobird.com/podcast/let-s-talk-risk-podcast-6693844)
Published: 2026-06-19T12:00:00+00:00
Episode link: https://naveenagarwalphd.substack.com/p/case-study-fdas-new-expectation-forfor-use-related-risks
Audio file: https://api.substack.com/feed/podcast/201611385/00ac148a7e3e69c31541d50281d6c5ec.mp3
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JSON: https://stenobird.com/v1/public/podcasts/let-s-talk-risk-podcast-6693844/episodes/case-study-fda-s-new-expectation-for-use-related-risk-in-medical-device-submissions
Duration seconds: 2486

## Resource

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 submissions, use-related risk analysis, critical tasks, Category 3 human factors validation, Decision Point D, eSTAR, QMSR, medical device usability, post-market surveillance, design validation, medical device labeling. 🎧Click Play above to listen to a brief audio summary about this case and lessons QA/RA and Clinical professionals can apply in practice using the newly released FDA Guidance. Thanks for reading Let's Talk Risk! . If you liked this post, share with others. Note: The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for thi…

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## Transcript

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