Medical Device Clinical Investigations: An Introduction 

Determine when an investigational device exemption (IDE) is needed. Learn the components of Institutional Review Boards (IRBs). Recognize the requirements elements of informed consent. Understand the responsibilities of a clinical trial sponsor. Learn what bioresearch monitoring (BIMO) looks for in a clinical trial inspection.

Anisa Mohanty, Counsel, McDermott Will & Emory

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in November 2022. 

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