This Medical Device training will describe critical issues that arise in the advertising and promotion of medical devices.
This medical device training will include a discussion on what constitutes valid scientific evidence to support advertising and promotional claims, a review of relevant Warning Letters to better understand FDA’s policies regarding comparisons to competitor products and what constitutes off-label use. Also presented will be examples of successful and problematic advertising and promotional strategies, including misleading claims.
The presentation will wind down with a discussion of FDA post-market compliance policies, types and examples of punitive enforcement actions, and recent trends in enforcement activities which suggest that FDA may now hold medical device manufacturers to a higher standard than previously.
Areas Covered in the seminar:
- What are the critical issues that arise in advertising and promotion of medical devices.
- What constitutes valid scientific evidence to support advertising and promotional claims.
- What are the rules and regulations for off-label use of medical devices.
- What types of promotional claims go too far and run the risk of generating a Warning Letter from FDA.
- What data are necessary to compare your product to a competitor’s product.
- Examples of successful and problematic advertising and promotional strategies.
- The current FDA environment for post-market compliance of medical devices.
- Examples of punitive enforcement actions.
- Why FDA may now be holding medical device manufacturers to a higher standard than previously, especially regarding misleading claims and off-label use.
Who will benefit:
This webinar will provide valuable assistance to all medical device manufacturers.The employees who will benefit include:
- Regulatory Affairs
- Marketing Department
- Compliance Specialists
- Clinical Project Leaders
Instructor Profile:
Stuart Portnoy, MD is Senior Consultant, Medical Devices, Biologics Consulting Group, Inc., where he advises medical device manufacturers regarding regulatory strategy, clinical trial design issues, and technical considerations to gain FDA market-approval for their products. He previously worked as a consultant at PharmaNet for 5 years and before that, at FDA for 8 years including positions as Branch Chief of Interventional Cardiology Devices and Acting Deputy Director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health. While at FDA, Dr. Portnoy performed the clinical review of a wide range of cardiac devices and was an agency leader in developing the now well-established multicenter review practices for evaluating drug-eluting stents and other combination products. Dr. Portnoy is a graduate of George Washington University School of Medicine and also has an MS in Bioengineering from the University of Pennsylvania.
