The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included in marketing submissions for medical devices.
The framework explores how to determine the human factors submission category and what to include in a marketing submission based on that category. Including appropriate human factors information in the marketing submission can improve the efficiency of the agency review by reducing the number of requests for additional information, according to the draft guidance.
“The goal of the human factors assessment is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible,” the agency wrote in the draft guidance. “The main factors to consider in a risk-based approach to human factors assessment, as described in this draft guidance, include the identification of (i.e., presence of or modification to) critical tasks and the elimination or reduction of use-related hazards.”…
