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

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.