Medical Device Clinical Investigations: An Introduction to Investigational Device Exemptions (IDEs), Institutional Review Boards (IRBs) and Informed Consent

Review the definition of Investigational Device Exemption and determine when an IDE is needed. Examine the components of Institutional Review Boards and the elements of informed consent.

Blake E. Wilson, Senior Associate, Hogan Lovells US LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2020. 

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