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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…

New FDA Guidance for Medical Device Human Factors

Reading Time: 4 minutes In December of 2022, FDA released its latest guidance on human factors in medical device marketing submissions. The purpose of the new document is to complement and provide some clarifications to the existing guidance document,…

Human Factors and FDA: Instructions for Use (IFU)

Reading Time: 6 minutes Instructions for Use (IFU) Instructions for use (IFU) are essentially the user manual for a medical device, providing information such as: How to use the device Why and when the device should be used Technical…

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…

FDA Medical Device Approval: Why Hire a Human Factors Expert

Reading Time: 5 minutes Healthcare Human Factors Engineering Human Factors Engineering focuses on designing products that match human capabilities and account for human limitations. This makes products easier to use, more effective, and safer. This is critical when designing…

6 Myths About Human Factors Engineering and the FDA

Reading Time: 5 minutes Human Factors Engineering and FDA Clearance Human factors validation testing and obtaining FDA clearance can be challenging. Even folks who fully understand these processes can struggle to execute efficiently. Where do these challenges come from?…