Hardware Podcasts

147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup

Let's Combinate · 30 Jul 2024 · 23m

What this episode covers

David Grosse-Wentrup, Research Director at Design Science Group, explains the FDA's new URRA draft guidance, which formalizes the use of Use-Related Risk Assessments (URRA) to justify waiving full human factors validation studies for medical devices.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.

Most relevant to

established companies

Topics

Mentioned

Companies
FDA, Design Science Group
Also
URRA, uFMEA, threshold analysis

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