FDA Human Factors/ Usability Engineering Guidance.

FDA issued a final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices”. This replaces the 2011 draft guidance.

This guidance does not include software-specific usability design requirements but focuses on overall aspects of human factors and usability in general. Software and computer interfaces are mentioned in several places as important elements to consider. There is also an interesting reference on Page 35 to a 2003 study that identified the number of users needed to find most computer user interface problems.While this may not be directly relevant to identigying medical device usability and safety it probably provides some basis for defending the number of user chosen for usability testign to FDA reviewers.

This guidance defines Use Safety as a specific term in addition to Use Error.

Section 4 discusses HFE (Human Factors Engineering) /UE (Usability Engineering) in relation to medical device risk anlysis and Section 7 discusses Elimination or Reduction of Use-related hazrds.

Section 5. discusses considerations related User Types, User Environments, and User Interface.

Section 6 discusses preliminary analysis and Section 7 discusses Human Factors Validation Testing.Section 6.2 lists a variety of public databases and information to consider when to identify known use-related problems.

Section 8 discusses documentation of HFE/UE.

SoftwareCPR provides expert consulting services in all aspects of Human Factors and Usability Engineering for Medical Devices.

The full guidance is at the link provided.

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