# 104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-09-27
- Length: 36m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/104--New-FDA-Guidance--HF-vs--Design-Validation--Critical-Tasks--Pre-IND-HF-Studies-with-Sara-McNew-e29qa23

## Summary

Sara McNew, Chief Scientific Officer at Design Science, discusses the new FDA Guidance on Human Factors for Combination Products, clarifying the distinction between human factors validation and broader design validation. She explains that pre-IND studies must demonstrate that clinical trial participants can use the device correctly to ensure accurate pharmacokinetic data, requiring a hybrid of formative and summative rigor. McNew details how critical task definitions now include administration and dosing errors, not just serious harm, and emphasizes the importance of submitting comprehensive Use Related Risk Assessments (URRA) alongside HF summaries.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=0) Introduction: Sara McNew and Design Science
- [2:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=120) FDA Guidance Q&A Format and Use Related Risk Assessment
- [4:38](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=278) Human Factors Validation vs. Design Validation
- [7:24](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=444) Pre-IND Human Factors Studies for Clinical Trials
- [13:15](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=795) Critical Task Definitions and Serious Harm Nuances
- [18:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=1121) Pre-Submission Reviews and Supplemental Studies
- [20:30](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=1230) Use Related Risk Analysis (URRA) vs. UFMEA
- [26:15](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=1575) Labeling Reviews and IFU Negotiations
- [30:42](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w#t=1842) International Human Factors Requirements and ISO 62366

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Design Science (company)
- FDA (other)
- ISO 62366 (other)
- HE 75 (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)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [How to Integrate Usability into your Medical Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-01-how-to-integrate-usability-into-your-medical-device) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-27-104-new-fda-guidance-hf-vs-design-validation-critical-tasks-pre-ind-hf-studies-w. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.