# 147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-07-30
- Length: 23m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/147---URRA-Draft-Guidance--uFMEAs--Design-Validation--HF-Summative--Comparative-Analysis--Threshold-Analysis-and-Compelling-Technical-Arguments-with-David-Grosse-Wentrup-e2mkmkn

## Summary

David Grosse-Wentrup, Research Director at Design Science Group, explains the FDA's new URRA draft guidance, which formalizes the use of Use-Related Risk Assessments (URRA) to justify waiving full human factors validation studies for medical devices. He details how to build compelling arguments using comparative analysis, threshold analysis, and historical data to demonstrate that a new product is sufficiently similar to an already approved reference device. The discussion covers the practical differences between a URRA and a use-related Failure Mode and Effects Analysis (uFMEA), emphasizing that the URRA is a distilled subset of the uFMEA specifically tailored for regulatory submission. Grosse-Wentrup also highlights lifecycle management strategies, noting that while the URRA is submitted to the FDA, the underlying uFMEA must be maintained throughout the product's life.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys#t=0) Introduction to URRA Draft Guidance
- [2:35](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys#t=155) Waiving Validation Studies via URRA
- [5:02](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys#t=302) Threshold Analysis and Reference Data
- [11:23](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys#t=683) Business Risk and Submission Strategy
- [14:35](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys#t=875) URRA vs. uFMEA Differences
- [17:16](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys#t=1036) Lifecycle Management of Risk Documents
- [18:48](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys#t=1128) Comparative Analysis and Real-World Examples

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

established companies

## Mentioned

- FDA (company)
- Design Science Group (company)
- URRA (other)
- uFMEA (other)
- threshold analysis (other)

## Related episodes from other shows

- [#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-03-09-450-human-factors-vs-clinical-trials-why-your-medtech-submission-is-stalling) (Global Medical Device Podcast)
- [Human Factors & Risk Management: What's Needed & Why?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-02-human-factors-risk-management-whats-needed-why) (Global Medical Device Podcast)
- [Setting the Record Straight on Usability & Human Factors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors) (Global Medical Device Podcast)
- [Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know) (Global Medical Device Podcast)
- [Tips for Being Prepared Post-EUA (Emergency Use Authorization)](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization) (Global Medical Device Podcast)

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