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.

Scott D. Danzis, Partner, Covington & Burling LLP
Amy Leiser, Associate, Covington & Burling LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in November 2022. 

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