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.