U.S. MedTech Marketing: Navigating FDA & FTC Rules

Medical Device Global Market Access

This episode delves into the essential U.S. regulations governing medical device marketing and advertising. We explore the roles of the FDA and FTC, key requirements for truthful and substantiated claims, the prohibition of off-label promotion, and how device classification impacts oversight. Learn about navigating online advertising, social media compliance, and the potential consequences of non-adherence, ensuring your promotional activities are both effective and lawful. Key Questions: • What are the primary goals of U.S. medical device marketing regulations? • How do the roles of the FDA and FTC differ in overseeing medical device advertising? • What constitutes a "restricted" versus a "non-restricted" medical device, and how does this affect marketing rules? • What kind of evidence is required to substantiate marketing claims for medical devices? • Is it permissible to promote a medical device for uses not approved by the FDA? • How should risks and benefits be presented in medical device advertising? • What are the specific considerations for advertising medical devices on social media? • What are the potential penalties for non-compliant medical device marketing in the U.S.? • How can companies ensure their marketing materials meet regulatory standards before publication? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.