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New US FDA Guidance on Human Factors Engineering for Medical Devices

US regulators lay out recommendations for HFE information to include in medical device registration applications

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December 8, 2022

The US Food and Drug Administration has issued a new draft human factors engineering (HFE) guidance this week titled: Content of Human Factors Information in Medical Device Marketing Submissions.

A forthcoming regulatory update from the Emergo by UL team will provide more details on the guidance, as well as our perspective on its impact for the application of HFE to medical technology.

Emergo by UL Solutions provides support throughout the usability engineering process:

  • Research – Research user needs to support design input.
  • Analyze – Task analysis, know problem analysis and use-related risk analysis.
  • Design – Develop designs that are intuitive, easy to use and that reduce the risk of use errors.
  • Evaluate – Formative and summative evaluation support at each stage of product development.
  • Training – We offer seminars and workshops upon request.

For any questions or requests regarding usability engineering, please contact us.


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