2015 Webinar: FDA Oversight and IRB Review of Studies that Include In-Vitro Diagnostics

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IVD products are medical devices or biological products intended to diagnose disease or determine a state of health. The US Food and Drug Administration (FDA) regulates investigations involving IVDs under the investigational device exemption (IDE). To support this work, IRBs must recognize when a study is using an IVD that is investigational, and determine whether it meets the criteria for an exempt device, a non-significant risk (NSR) device, or a significant risk (SR) device. 

The rapid growth and application of genomic testing in clinical trials and the use of IVDs to select patients for drug trials in particular pose unique challenges for IRBs and investigators in this regard. IRBs, investigators, and sponsors often struggle with correctly identifying when an IVD is being used in manner that makes it investigational, and correctly determining the risk level for the device.

During this webinar, presenters:

  • Provided an overview of FDA regulatory framework in relation to IVDs
  • Explained the application of IDE regulations to studies with IVDs
  • Highlighted complex IRB scenarios and share processes developed by one institution through the use of case studies

What Will I Learn?

By the end of this intermediate-level webinar, participants were able to:

  • Identify key processes for the IRB review of IVDs in clinical trials
  • Assess when the use of an IVD in a clinical trial is investigational
  • Understand when an investigational IVD is exempt from the IDE regulations
  • Determine when an investigational IVD is NSR or SR
  • Aid investigators and IRBs when designing and/or evaluating clinical trials

Who Should Attend? 

IRB chairs, members, administrators, and staff; institutional officials; and investigators will benefit from attending this webinar.


Jonathan M. Green, MD, is professor of medicine, pathology, and immunology, as well as associate dean for human studies, and executive chair of the institutional review board at Washington University School of Medicine in St. Louis, MO. He received his medical degree from Wayne State University followed by residency training in internal medicine at Boston City Hospital (now Boston Medical Center).  He then completed a fellowship in pulmonary and critical care medicine at the University of Michigan, and additional post-doctoral training at the University of Chicago. He is board certified in internal medicine, pulmonary diseases, and critical care medicine. Currently, Dr. Green is an attending physician in the Medical Intensive Care Unit at Barnes-Jewish Hospital, and conducts both basic science and clinical research on the regulation of the immune response. Dr. Green also serves as a member of PRIM&R’s Education Committee.

E. David Litwack, PhD, currently serves as personalized medicine staff at the Office of In-Vitro Diagnostics and Radiological Health at the US Food and Drug Administration. Since 2012 he has developed policies to guide the review of investigational biomarker tests and companion diagnostics. In 2010, Dr. Litwack was awarded the American Association for the Advancement of Science’s Science and Technology Policy Fellowship in National Cancer Institute’s Office of Biorepositories and Biospecimen Research. During this fellowship, he led several efforts to develop policy and programs to advance the use of biobanking for personalized medicine. Dr. Litwack received a BS in chemistry from the University of Chicago, and a PhD in Biology from the Massachusetts Institute of Technology. After postdoctoral studies at the Salk Institute for Biological Studies, he joined the University of Maryland School of Medicine as an assistant professor in the department of anatomy and neurobiology and a member of the program in neuroscience. In that role, Dr. Litwack directed an NIH-funded lab that studied the role of transcription factors in neurogenesis in the mammalian brain and in human embryonic stem cells, and was a founding member of the School’s Center for Stem Cell Biology and Regenerative Medicine.   

Certificates of Attendance

Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext. 0.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours. 

Additional information about CIP® recertification can be found here

Webinar Recording Information

All of our webinars are recorded and available for purchase and/or access.

  • Webinar registrants receive access to the recording at no additional charge. The link to the recorded presentation will be emailed to all attendees within a week of the webinar’s completion. For individual registrations, the archive link is intended for the use of the webinar registrant only. 
  • For anyone unable to attend the live presentation, the webinar archive is available for purchase. The price to access the recording only is the same as the price to register for the live presentation (and receive access to the recording). To gain access to any current or past webinars, please complete the order form and send it to us either via fax (617.423.1185) or email.
  • PRIM&R members have complimentary access to select past webinar archives (usually, those that originally aired more than a year ago, or that were offered complimentary to PRIM&R members). These webinar recordings can be accessed in the online Knowledge Center.

If you have additional questions about webinar archives, please contact us by phone (617.423.4112, ext. 1876) or via email.