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Return to Article: Understanding Human Factors

According to FDA, usability testing can be done in a variety of ways in various degrees of complexity and formality. However it is done, it should include the following:

• An overall goal of improving the usability, including safe and effective device use.
  
• Test participants represent intended users.
  
• Test participants do real tasks, particularly tasks that will indicate whether safe and effective use is achieved.
  
• Focus on high-risk-use scenarios.
  
• Testers who observe and record important aspects of what test participants do and say (participants can also respond to questionnaires, or be interviewed following the use of the device).
  
• Data collected to support the identification of potential use-related hazards and the development of specific recommendations to address them.