FDA Update May 30, 2012:

Draft Guidance: Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design.

FDA has developed this draft guidance document

  • To assist industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.
  • To improve the usability of devices to reduce use error, injuries from medical devices, and product recalls.

The most important aspect of sampling may be

  • the extent to which the test participants correspond to the actual end users of the device, which requires that you accurately identify and describe your user populations.
  • For devices with multiple user populations that have different personal characteristics, it may be advisable to test the maximum number of participants that your budgets and schedules allow.
  • Your employees should not be test participants except in rare cases when all users necessarily are employees of the manufacturer.
  • To adequately represent users in the United States population, the participants in the validation test should reside in the United States. English fluency or first-language abilities should only be used as a test participant inclusion criterion if this requirement is also stated in the device labeling.  

When final, this document will supersede Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.

As part of their design controls, manufacturers conduct a risk analysis that includes risks associated with device use. If the results of this analysis indicate that there is a moderate to high risk of use error, or if a manufacturer is modifying a marketed device due to problems associated with use, particularly as a corrective and preventive action (CAPA), then the manufacturer should perform appropriate human factors testing according to this guidance document.

FDA staff may request human factors testing if: (i) submission of human factors information is required (for example, as a special control); (ii) submission of human factors information is recommended in a specific guidance for a device type and the manufacturer cannot justify forgoing such testing; or (iii) on a for-cause basis if it is the least burdensome method to address FDA’s concerns regarding human factors issues. Under these circumstances, manufacturers should provide FDA with a report that summarizes the human factors processes, evaluations, and results of validation testing as part of their pre-market applications or submissions

To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used. Understanding and optimizing how people interact with technology is the subject of human factors engineering (HFE) and usability engineering (UE).

HFE/UE considerations that are important to the development of medical devices include three major components of the device-user system: (1) device users, (2) device use environments and (3) device user interfaces.


The advantages of optimizing device design through application of HFE/UE extend beyond improved safety. Many device manufacturers have found that the application of HFE/UE in the design of their products reduces the need for modifications and costly updates after market introduction and offers competitive advantages. With increased safety, the likelihood of your incurring expenses associated with product recalls or liability is reduced; when HFE/UE approaches are used in the design of devices, particularly if the perspective of users is taken into account, the overall ease of use and appeal of a device can simultaneously be enhanced.

For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259760.pdf" you can contact mdi at info@mdiconsultants.com and ref: HFE/UE. You can also call mdi at 516-448-0393 and ask for one of our senior consultants to assist you.