FDA Issues Guidance on Applying Human Factors and Usability Engineering to Medical Devices
The U.S. Food and Drug Administration has issued the guidance “Applying Human Factors and Usability Engineering to Medical Devices”, dated 3 August 2026.
The guidance is intended for industry and FDA staff and represents FDA’s current thinking on the application of human factors and usability engineering to medical devices. FDA notes that the document contains nonbinding recommendations and does not establish legally enforceable responsibilities.
Purpose of the Guidance
FDA explains that the guidance is intended to assist industry in following appropriate human factors engineering and usability engineering processes so that new medical devices are more likely to be safe and effective for their intended users, uses and use environments.
The recommendations are intended to support manufacturers in improving device design, minimizing potential use errors and reducing risks associated with medical device use.
Scope and User Interface Focus
The guidance recommends that manufacturers follow human factors or usability engineering processes during the development of new medical devices, with a specific focus on the user interface.
FDA defines the user interface broadly, including all points of interaction between the product and users, such as displays, controls, packaging, product labels and instructions for use. The goal is to ensure that use errors that could cause harm or degrade medical treatment are eliminated or reduced to the extent possible.
Human Factors as Part of Risk Management
The guidance emphasizes that human factors and usability engineering should be incorporated into device design, development and risk management processes.
FDA identifies three essential steps for successful HFE/UE analysis:
identify anticipated and initially unanticipated use-related hazards;
develop and apply risk control measures to eliminate or reduce hazards that could result in harm;
demonstrate that the final user interface supports safe and effective use through human factors validation testing.
The figures in the guidance illustrate how users, use environments and user interfaces interact during device use, and how these interactions may result either in safe and effective use or in unsafe or ineffective use.
Device Users, Use Environments and User Interface
FDA recommends that manufacturers review and document the essential characteristics of intended users, use environments and the device user interface before conducting HFE/UE analyses.
This includes intended user groups, physical, sensory and cognitive capabilities, training expectations, clinical or non-clinical use environments, alarms, displays, controls, software interfaces, packaging, labeling and training materials.
Preliminary Analyses and Critical Tasks
The guidance describes preliminary analyses and evaluations as a way to identify user tasks, user interface components and use issues early in development.
A key output is the identification and categorization of critical tasks — tasks that, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user. FDA notes that risk analysis tools such as FMEA and fault tree analysis can support this process.
Human Factors Validation Testing
FDA explains that human factors validation testing is conducted to demonstrate that the device can be used by intended users without serious use errors or problems, for the intended uses and under expected use conditions.
The test should include representative users, all critical tasks, a final user interface design and sufficiently realistic test conditions. FDA also recommends that manufacturers consider submitting a draft human factors testing protocol through the Q-Submission Program before conducting the test.
Impact on Medical Device Manufacturers
For medical device manufacturers, the guidance reinforces the importance of integrating human factors and usability engineering throughout the design and development process.
Manufacturers should pay particular attention to:
user interface design;
intended users and use environments;
use-related hazards;
risk management integration;
identification of critical tasks;
formative evaluations;
simulated-use testing;
human factors validation testing;
final labeling and training materials;
residual risk analysis;
documentation for design files and marketing submissions.
For manufacturers developing or modifying medical devices, the guidance highlights that usability and human factors are not only design considerations, but also key elements of risk control, design validation and regulatory readiness.
