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  1. Human Factors and Medical Devices

Human Factors Engineering Team

Human Factors at Center for Devices and Radiological Health (CDRH)

The purpose of CDRH’s Human Factors Engineering Team is to help ensure that medical devices have been designed to be safe and effective when used by the intended user populations. The team is primarily involved in reviewing device submissions, and promoting effective and focused human factors evaluation and good design practices for medical devices.

In addition, the team:

  • Develops and provides content for FDA guidance documents to help manufacturers understand and apply human factors engineering and/or usability engineering.
  • Conducts outreach to industry and academia through presentations at conferences and public meetings.
  • Provides training and expertise for other FDA personnel about human factors, use-safety, and design of medical devices.
  • Participates with National and International Standards committees in the development of Human Factors-related Standards.
  • Encourages users and manufacturers to report serious adverse incidents involving medical devices through the FDA's Medical Device Reporting (MDR) system.
  • Contributes to the analysis involving post-market reports and recalls of medical device in which use error is involved.

Questions?

Please email the CDRH Human Factors Engineering Team at HFPMET@fda.hhs.gov with any questions.

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