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Tag: risk analysis

Simplifying the 2023 FDA Guidance on Human Factors Engineering Principles for Combination Products

Reading Time: 4 minutes Like with all medical devices, the application of human factors principles is essential for the development of safe and effective combination products. On September 7, 2023, the FDA released “Application of Human Factors Engineering Principles…

Five Tips for Human Factors Engineering and FDA

Reading Time: 5 minutes Human factors engineering focuses on researching, designing, and evaluating products to make them useful, usable, desirable, and safe. Healthcare human factors engineering emphasizes safety. In fact, during the premarket submission process, the U.S. Food and…

Human Factors and the FDA: Buzzwords

Reading Time: 3 minutes Human Factors and FDA Submissions Medical device manufacturers cannot legally market their products without clearance or approval from the Food and Drug Administration (FDA). Unfortunately, navigating this regulatory jungle can be a bit of a…