Review the scope of FDA authority concerning medical device promotion and advertising. Define key statutory definitions of “label” and “labeling” and “false and misleading”. Discuss off-label issues, claims substantiation, and Direct-to-Consumer (DTC) Advertising.
Suzanne Levy Friedman, 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 March 2021.