Guidance for Industry and FDA Reviewers on Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled "Medical Device Use-- Safety: Incorporating Human Factors Engineering into Risk Management." This guidance describes how to incorporate human factors techniques and theory into risk management during medical device design and development. The guidance is intended to assist reviewers of premarket device submissions, design control documentation, and manufacturers that develop devices. The guidance is necessary to decrease problems with the use of medical devices that impact safety and effectiveness, and help ensure safer and more effective devices.