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.
Carolina Wirth,Of Counsel, Arnall Golden Gregory LLP
Genevieve M. Razick, Associate, Arnall Golden Gregory LLP
This session was recorded as part of FDLI's Virtual Introduction to Medical Device Law and Regulation Course in April 2020.