2009 Webinar: Introduction to Medical Device Research and Making the Risk Determination

Webinar Archives - Members  Webinar Archives - Non-Members


This device-specific webinar, designed by the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, focused on basic information members of institutional review boards (IRBs) should know about medical device research including the sponsor and clinical investigator responsibilities.  This webinar also covered the FDA’s recommended procedures of how an IRB should meet its regulatory requirement to make a risk determination of non-significant risk device studies.  In addition, there will be a brief demonstration of how to locate PMA and 510(k) devices labeling information.

  • Introduction to Investigation Device Exemption (IDE)
    • Discussion about when an IDE is necessary and when it is not 
    • Sponsor responsibilities and interactions with IRB
    • Clinical investigator responsibilities and interactions with IRB
    • IDE studies supporting marketing applications
    • Tools to find approved labeling of cleared 510(k)s and Premarket Approvals
    • 21CFR 812.66 the IRB responsibility to make a risk determination
  • The IRB Significant Risk vs. Non-significant Risk Determination
    • Discussion of significant risk device
    • How IRB's should go about determining the risk of a non-significant risk device study
    • The role of the sponsor, clinical investigator, IRB, and FDA


Fabienne Santel, MD
Dr. Fabienne Santel is the medical officer at the Division of Bioresearch Monitoring at FDA Center for Devices and Radiological Health (CDRH). Dr. Santel is the primary clinical contact within the Division and supports Division staff in the development and review of complaints or inspection reports that reveal deliberate or repeated non-compliance with regulations governing investigational device research or associated human subject protection. Dr. Santel is also a clinical reviewer at CDRH Office of Device Evaluation where she provides clinical reviews to ensure the quality, reliability, and integrity of data and information submitted in support of investigational and marketing applications (IDEs, PMAs, 510(k)s, and HDEs).  Dr. Santel is physician, board certified in internal medicine with a concentration in hospital based medicine. She received her undergraduate training at the University of Maryland at College Park and obtained her medical degree from the SUNY Downstate Medical Center in Brooklyn, New York. She trained in internal medicine at the Albert Einstein College of Medicine Jacobi Medical Center with a special concentration in women's health. After completion of her residency Dr. Santel conducted academic research through the Empire State Research Fellowship, specifically looking at the incidence of undiagnosed chronic medical diseases (diabetes, coronary artery disease) in medically underserved populations. Dr. Santel has experience as a practicing physician, academic researcher, and regulatory official.

Marian Serge, RN
Marian Serge is a registered nurse with past experience as a research coordinator in Department of Clinics, Wake Forest University School of Medicine; a clinical research associate in the Institute of Neurological Disorders and Stroke at National Institutes of Health (NIH); and as a project officer and a regulatory affairs specialist in the Division of AIDS, National Institute of Allergy and Infectious Diseases at NIH. She began her career at FDA in the Center for Devices and Radiological Health in 1997. Ms. Serge is a nurse consultant and peer review expert in Human Subject Protections in the Division of Bioresearch Monitoring, Office of Compliance. She received her nursing degree from Forsyth Technical College, Winston-Salem, NC and a Certificate of Completion, Neurology/Neurosurgery Nurse Specialty Course from Bowman Grey School of Medicine, Wake Forest University. She has attended numerous PRIM&R conferences both as a faculty member and as a participant.