C06 - Medical Devices: A Beginner's Guide to Understanding the Basics of FDA Regulation and How to Apply it to a Study

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IRBs have an important role in reviewing and approving the use of investigational medical devices, as well as ensuring investigators comply with all applicable regulations for these devices. Despite the available resources, understanding FDA regulations regarding investigational medical devices often feels overwhelming and complex for IRB reviewers and HRPP staff, and can be a source of frustration for researchers. This session will introduce basic terminology pertaining to FDA regulations and walk through the different decision pathways for Investigative Device Exemptions (IDEs) as well as describe the responsibilities of the IRB determined by the review pathway.