An Introduction to the Regulation of Promotion and Advertising for Medical Devices
A session from FDLI’s Introduction to Medical Device Law and Regulation
Recorded April 9, 2025
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.
Suzanne Levy Friedman, Counsel, Hogan Lovells US LLP
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2025.
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SUZANNE LEVY FRIEDMAN is a Senior Associate in the FDA/Medical Devices practice group in Hogan Lovells LLP’s Washington, DC office. Her responsibilities include advising diverse clients on all aspects of medical device premarket and post-market issues, including helping companies determine the appropriate regulatory pathway for their new or modified products and preparing the associated submissions. A significant part of her practice involves guiding medical device and combination product manufacturers on the lawful promotion and advertising of their products, both as investigational devices before they are cleared/approved and once they are authorized for marketing. She also advises companies extensively on the “lines” differentiating regulated from unregulated software functions and products (including clinical decision support software, mobile apps, etc.). Suzanne is a member of the Regulatory Affairs Professional Society and the young lawyers division of the Food & Drug Law Institute. Suzanne received her BA in politics/international relations from Princeton University and her JD and Masters in Bioethics from the University of Pennsylvania.
































































































