Meet the Human Factors Staff
- Ron Kaye, MA, Human Factors Pre-Market Evaluation Team Leader
- Molly Follette Story, PhD, Human Factors and Accessible Medical Technology Specialist, SBRS
- QuynhNhu Nguyen, BS, Injection Systems Human Factors Specialist
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 firstname.lastname@example.org 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.
Molly Follette Story, PhD, Human Factors and Accessible Medical Technology Specialist, SBRS
Molly Follette Story, PhD is Human Factors and Accessible Medical Technology Specialist at the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE). She has an appointment to the Senior Biomedical Research Service. Previously, she served as a Senior Program Officer at the National Research Council of The National Academies. Before that she was President of Human Spectrum Design and Co-Director of the Rehabilitation Engineering Research Center on Accessible Medical Instrumentation. Dr. Story is an expert in universal design of products and in the accessibility and usability of medical instrumentation, has been granted six utility patents, and has served as a research and design consultant to a variety of companies. She is co-editor of Medical Instrumentation: Accessibility and Usability Considerations (CRC Press, 2007). Dr. Story coordinated development of and co-authored the Principles of Universal Design and co-authored The Universal Design File: Designing for People of All Ages and Abilities (North Carolina State University, 1998). Dr. Story is a member of HFES, AAMI, and RESNA and was a member of AAMI’s Human Factors Engineering Committee, which developed the standard, AAMI/ANSI HE75:2009, Human Factors Engineering – Design of Medical Devices. Dr. Story received a PhD and a MS from the School of Public Health at the University of California, Berkeley, a MS from Stanford University and a BSE from Princeton University.
QuynhNhu Nguyen, BS, Injection Systems Human Factors Specialist
QuynhNhu Nguyen is a biomedical engineer by training. She has been with FDA since 2005. She has been working with Human Factors evaluation originally with the MedSun project in Office of Surveillance and Biometrics, and now with DAGID’s Human Factors Premarket Evaluation Team in Office of Device Evaluation. Her regulatory experience also includes review a variety of premarket submissions: 510(k)s, IDEs, pre-IDEs with CDRH. She has also conducted both specialized biomedical engineering reviews and human factors reviews on a variety of combination products such as inhalation and auto-injection systems.