An Introduction to the Regulation of Promotion and Advertising for Medical Devices
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.
Carolina M. Wirth, Of Counsel, Hall, Render, Killian, Health & Lyman P.C.
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2023.