Meet the Human Factors Staff
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 2531
Silver Spring, MD 20993
- 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 e-mail DICE@fda.hhs.gov or call 1-800-638-2041.
Ron Kaye, MA, Human Factors Pre-Market Evaluation Team Leader
Mr. Kaye leads the Human Factors Pre-Market Evaluation Team which is located in the CDRH Office of Device Evaluation (ODE) and within the Division of Anesthesia General Hospital and Infection Control Devices (DAGID). Ron has a BS degree in Psychology and Biology, and a MA in Applied Psychology. He has worked in Human Factors for 30 years and has been with FDA’s Center for Devices and Radiological Health (CDRH) for 15. Prior to joining the FDA, Ron worked with Human Factors and human performance testing, training analysis, and research on safety-critical systems such as nuclear power plant control rooms, military weapons and communications systems, aircraft cockpit systems, air traffic control systems, and medical devices.