Tag: guidance

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,…

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…