Human Factors at Center for Devices and Radiological Health (CDRH)
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-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 review consultations.
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.
For Pre-Market Questions:
Human Factors Pre-Market Evaluation Team
Center for Devices and Radiological Health (CDRH)
Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (DAGID)
10903 New Hampshire Avenue
WO66, Room 2513
Silver Spring, MD 20993
Email: [email protected]
- Medical Device Reporting (MDR) – Contact Information for User Facilities and Manufacturers
- Where to Submit a Medical Device Report
- Postmarket Reporting by Health Professionals
- Postmarket Reporting by Consumers
For general questions about medical devices, please contact the Division of Industry and Consumer Education (DICE) at [email protected], 800-638-2041, or 301-796-7100.