Hardware Podcasts

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

Let's Combinate · 27 Sept 2023 · 36m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Design Science
Also
FDA, ISO 62366, HE 75

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