Human Factors Considerations For Combination Products

By Ana Ladino

In February of 2016, the FDA released a draft guidance regarding Human Factors and Related Clinical Study Considerations in Combination Product Design and Development. This paper highlights the human factors studies in the development in combination products, clarifies the difference between the studies, and discusses how the studies are part of the process to maximize the likelihood that the combination product user interface is safe and effective for use by the intended users, uses, and environments.