New York, NY
This session discusses the unique challenges associated with digitally manufactured products regulated by the Food and Drug Administration (FDA) such as food and medical devices. 3-D Printing presents an opportunity for numerous innovations including the potential for individuals to customize medical devices and food with specific details to meet each consumers need – such as specialized medical devices and personalized food with unique nutrient profiles and calorie content. Among other cutting edge innovations, companies are developing ways to monitor an individual's biostatistics and then create personalized food to match the needs of the person’s health status. Importantly, the "intended use" and "claims" for the product would govern whether pre-market FDA clearance or approval is necessary for market access. Our discussion focuses on how these innovations may exist within the framework of the FDA regulatory system for food, dietary supplements, drugs, and medical devices.
Speakers:
Claudia A. Lewis, Partner, Venable LLP
Heili Kim, Counsel, Venable LLP
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