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.