Review the scope of FDA authority concerning medical device promotion and advertising. Define key statutory definitions of “label” and “labeling” and “false and misleading”. Recognize off-label issues, claims substantiation, and Direct-to-Consumer (DTC) Advertising.
Scott D. Danzis, Partner, Covington & Burling LLP
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2022.