FDA Human Factors Documentation Support

Human factors engineering, or medical ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive abilities. The U.S. Food and Drug Administration (FDA) considers human factors engineering in device regulation because the safety of medical devices relies on them being used as intended, as well as their reliability. The FDA expects device developers to account for human factors within their processes.

The intent of the human factors process at the FDA is to ensure the development team demonstrates and documents:

• Understanding of the users, use environments, and user interfaces
• Understanding of user groups and their capabilities and limitations
• Understanding of intended environments where the device will be used as well as unsuitable environments
• Understanding of intended use and foreseen unintended uses of the device
• Efforts to identify use-related error
• Evidence for effective mitigations to user-related error