A draft of FDA human factors guidance has been published. It discusses methods for integrating human factors into product development, sample size requirements for usability testing, and comparison with IEC 62366-1. We will discuss these topics in detail to understand their implications for product development and design. Read on for more information!
Draft FDA Human Factors Guidance
The FDA recently released the Draft Human Factors Guidance (HFG) for medical devices and combination products. This document outlines the current expectations of the agency for HF testing, clinical considerations, usability engineering, and user error. It is essential for manufacturers of medical devices and combination products because of the possible public health risks associated with user error. The guidance will also assist manufacturers in their premarket submissions and HFE/UE-related processes.
The Draft FDA human factors guidance for combination products includes examples of simulated and actual usability studies. In addition, the guidance states that …