News & Updates

**Article Excerpt: Demystifying the FDA’s New Human Factors Guidance**

On May 29, 2026, the FDA issued a finalized guidance document. It introduces a brand-new, risk-based framework for medical device marketing submissions. Furthermore, this critical update requires manufacturers to classify their devices into one of three specific Human Factors (HF) Submission Categories. This classification relies heavily on a Use-Related Risk Analysis (URRA) and the presence of critical tasks. Read the full article to learn how to seamlessly navigate these new regulatory requirements, accurately determine your device’s category, and streamline your path to market.

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