Human Factors and Medical Devices
Human Factors Program at FDA
FDA works with manufacturers to help ensure the application of human factors engineering to the design of new products as well as to postmarket surveillance of currently marketed products.
Human Factors at Center for Devices and Radiological Health (CDRH)
Office of Device Evaluation (ODE)
The Human Factors Premarket Evaluation Team is located in the Office of Device Evaluation (ODE). The purpose of the FDA’s Human Factors Pre-Market Evaluation Team is to ensure that new medical devices have been designed to be reasonably safe and effective when used by the intended user populations. The effort primarily involves reviewing new device submissions, promoting effective and focused human factors evaluation and good design practices for medical devices.
The premarket team works with scientific reviewers across the Office to evaluate use-related risk analyses, and human factors/usability information and validation study data submitted as part of various types of premarket submissions (premarket notification [510(k)] submissions, premarket approval (PMA) applications, Investigational Device Exemption (IDE) applications, and Pre-IDE submissions). The team provides recommendations on human factors components of manufacturers' design validation documents as required by the FDA’s Quality System Regulation. The team also collaborates with colleagues in other FDA Centers by providing human factors recommendations, such as for combination products (i.e. autoinjectors, pen injectors, inhalation products, pre-filled syringes, etc.) in their pre-approval review processes.
In addition, the team:
- Develops and provides content for FDA Guidance documents to help manufacturers understand and apply human factors engineering.
- Conducts outreach to industry and academia through presentations at conferences and public meetings.
- Provides training and guidance 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.
Human Factors Engineering of Combination Products and the FDA (July 2012)(PDF - 332KB) FDA Perspectives on Human Factors in Device Development (June 2012)(PDF - 954KB) FDA Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions (March 2012)(PDF - 659KB) The FDA Perspective on Human Factors in Medical Device Software Development (February 2012)(PDF - 1MB) Meet the Human Factors Pre-market Review Team at FDA’s Office of Device Evaluation, 2011 HFES Annual Meeting (September 2011)(PDF - 1.1MB)