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.

Justine E. Lenehan, Associate, Kleinfeld, Kaplan & Becker, LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2023. 

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