FDA-CDRH Guidance on Human Factors

On February 3, 2016, FDA-CDRH issued a final guidance document entitled Applying Human Factors and Usability Engineering to Medical Devices. The guidance document recommends applying human factors in a risk management setting as a particular instance of ISO 14971:2007. In particular, the guidance discusses use-related hazards as a particular type of hazard. Use-related hazards might result from aspects of the user interface design that cause the user to fail to adequately or correctly perceive, read, interpret, understand or act on information from the device.

The guidance advises that because probability is very difficult to help determine the risk of use errors, the severity of the harm is more meaningful for estimating risk and evaluating the need for risk control.

In addition, a draft guidance, List of Highest Priority Devices for Human Factors Review, dated February 3, 2016, lists sixteen device types, some with multiple product codes, for which a premarket submission should include human factors data.