Human Factors Considerations for Combination Products

This technical report summarizes the recent guidance issued by the Food and Drug Administration (FDA) regarding the application of human factors engineering principles for combination products. The guidance emphasizes the importance of conducting human factors activities for products that combine a device with a drug or biologic. It outlines the necessity for manufacturers to collaborate on comprehensive evaluations of use-related risks, critical tasks, and user interfaces. The report details the process of conducting a Use Related Risk Analysis (URRA) to identify potential hazards associated with the combination product and emphasizes the determination of critical tasks that could lead to patient harm if not performed correctly. Additionally, it discusses the user interface's role in ensuring safe interactions and the importance of formative and summative evaluations in validating the product's usability. The guidance also addresses lifecycle management and the need for ongoing evaluations in response to changes in the product or regulatory environment.