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FDA's Human Factors Program - Promoting Safety in Medical Device Use (photo montage)
Human Factors Home
Information for Manufacturers
Information for Health Care Professionals
Information for Consumers
Presentations and Research
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Human Factors

Human factors is the science and the methods used to make devices easier and safer to use. The Human Factors team advances the FDA’s patient safety mission by distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. We work with manufacturers to help ensure the application of Human Factors engineering to the design of new products. We also help device users through identification and investigation of use-related errors.

Information for Manufacturers and Distributors

  • Quality system/design control regulation
  • Human factors guidance
  • Medical device labeling information
  • FDA recognized standards

Information for Health Care Professionals and Engineers

  • Use error reporting
  • FDA resources on patient safety and human factors
  • Selection and maintenance of medical devices
  • FDA-developed training
  • Patient safety websites

Information for Consumers

  • Checklists and brochures
  • Consumer websites

Presentations and Research

Other Human Factors Resources

  • FDA information
  • Other government reports
  • Human factors training
  • Special population considerations
  • Other human factors and medical device sources

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Updated October 5, 2006

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