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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.

Elizabeth Mulkey, Associate, Goodwin Procter LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2024.

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Kiana Walker2024-11-25T14:01:29-05:00