Anticipating When the FDA Will Treat Your Product as a Drug-Device Combination

January 17, 2018

Webinar

Jake M. Holdreith

Partner

Member of the Executive Board

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

The FDA considers a product a drug-device if it includes at least two of the following: a drug component, device component, or a biologic component. The FDA does not classify as a combination product, one that consists of similar components, e.g., drug-drug or device-device. However, bringing a combination device to market requires careful consideration of your strategy. During this session we will discuss the legal consequences of bringing your combination product to market from both a regulatory and patent litigation perspective.

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