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. (Presented on May 14, 2015)
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.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
Access to purchased content will be available for 90 days after the date of purchase. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. Content purchased prior to January 1, 2021 will remain available indefinitely. After access has expired, users can purchase an additional 90 days of access.
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