Advertisement & Promotional Material

In the US, the regulatory landscape for medical device advertising is complex, and multiple agencies including FDA and FTC are involved. There are some clear “no-go” zones; other areas which are innocuous; and a large area in between where the answers are nuanced.



This uncertainty can create tension between marketing and regulatory teams when reviewing marketing collateral. Having consistent but flexible processes; with aligned definitions of risk; and clear accountability on decision-making can alleviate many of these concerns. It also sets the foundation for a smoother partnership with marketing in the creation of advertisement & promotional material.



In this seminar, participants will learn the various types of risks involved in advertisement and promotional material, and how to classify them into buckets that are meaningful to organizational leaders; the key elements of a robust review process that allows for flexibility and nuanced review; and the procedural requirements to allow for efficient approval of marketing collateral.



Participants will be presented with various types of materials, and an experienced team of panelists from clinical, legal, and regulatory affairs background with multiple years of experience navigating complex Ad/Promo situations will provide their perspectives. This is an interactive session with examples and practical guidance.