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

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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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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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