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Navigating the FDA’s Draft Human Factors and Usability Engineering Guidelines

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The FDA provides a wealth of information about how to implement human factors processes in the design of medical devices, throughout the product lifecycle, with the goal of improving “the usability of devices to reduce use error, injuries from medical devices, and product recalls.”

While certainly a laudable goal, this body of knowledge can oftentimes be overwhelming and vague to industry outsiders, leaving readers wondering what to do next or where to even begin. In this post we’ll introduce the overall content themes found in the FDA’s draft guidance on human factors and usability engineering (HFE/UE) and explain why they’re necessary.

Be sure to join us on August 26, 2015 @ 12pm CST for a 1- hour webinar where we'll share practical guidance for meeting the FDA’s guidelines for implementing human factors processes in medical device design.

THEME 1: HFE/UE Is a Process.

We all know that human factors and usability engineering is always a process and great user experiences are the result of careful planning and dedicated execution. The FDA outlines a high-level three step human factors and usability engineering process for the development of medical devices that follows industry best practices. The process starts with identifying use-related hazards (usually via a risk analysis), then proceeds to a testing and mitigation phase, and is finished up with a validation of safe use phase.


THEME 2: Users, User Interfaces, and Use Environments

The FDA recognizes that use-related hazards are a product of device users, device use environments, and device user interfaces, and that understanding the interaction between all three is essential for safe and effective medical device design. The FDA draft guidance document recommends that all intended user groups should be identified and evaluated, that actual use environments should approximated, and that all critical interaction pathways should be documented and evaluated.


THEME 3: Analytical & Formative Testing

The FDA specifies that part of your risk analysis includes the identification and evaluation of use-related hazards. One of the first steps in doing is to identify already known problems. An analysis of similar systems and known database searches can be helpful here. The next step is to choose one or more analytical techniques to investigate unknown use-related hazards, such as:

  • Contextual Inquiry
  • Interviews/Focus Groups
  • Function/Task Analyses
  • Heuristic Analyses
  • Expert Reviews

The FDA also recommends that formative evaluations take place during device development to inform the developmental process. There are a number of quantitative and qualitative formative evaluation techniques and choosing one depends on your research question. Notable examples include: 

  • Simulated Use (Usability) Testing
  • Cognitive Walkthroughs

THEME 4: Human Factors Validation Testing

Human factors validation testing conveys to the FDA that the medical device in questions can be safely and effectively used by the intended users in the intended use environment. While this is arguably the most important, time consuming, and resource intensive part of the HFE/UE process, the results of the validation testing should not be a surprise. Properly conducted and iterated analytical and formative testing should have already discovered all critical, and a vast majority of minor, use-related hazards.

The FDA specifies the following guidelines for conducting your human factors validation testing: 

  • Testing environments should be as realistic as possible.
  • All critical use case scenarios should be included in the test protocol.
  • A representative sample must be obtained and verified.
  • Fifteen (15) users per user segment should be evaluated.
  • Participant training should approximate real use training.
  • Both subjective (qualitative) and performance (quantitative) data should be collected and analyzed.
  • Newly discovered use-related hazards must be mitigated.
  • Any residual risk must be identified and documented. 

THEME 5: Documentation

The FDA requests that all HFE/UE reports submitted either proactively or by request conform to the following format: 

  1. Section 1: A summary of device users, device uses, use environments, and training requirements.
  2. Section 2: Technical description of the user interface.
  3. Section 3: A summary of known use-related hazards.
  4. Section 4: A summary of the analytical methods used plus results.
  5. Section 5: A summary of the formative evaluations included methodology and results.
  6. Section 6: A detailed reporting of the human factors validation testing.
  7. Section 7: Any concluding remarks and a summary of any residual risk.

Do you have other questions or comments about the FDA’s draft guidance on human factors and usability engineering? 

Are you interesting in conducting user research on your medical device or application?  Learn how Normal Modes can use usability testing and other user experience methodologies to answer your user research questions today.


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