Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.
The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.
This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.
This audio conference covers:
- The FDA shift in focus to indications
- What this means for medical device companies
- The difference between “indications for use” and “intended use”
- The need to establish bounds for your indications and stay within them
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- Where indications are headed in the future
About the speaker:
Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance, and Intellectual Property service areas. He is recognized as one of the leading FDA compliance attorneys and counsels pharmaceutical, medical device, biotech, and food and nutritional supplement companies on FDA policy. Previously, he served as a regulatory attorney for Medtronic where he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.
Robert frequently speaks at local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is an adjunct professor for the MBA program at St. Thomas University Graduate School of Engineering.
Who should attend?
- Regulatory Affairs
- Marketing
- Legal Counsel
- Management
This audio conference is classified as General Interest.