Drug-device combination products definition

Claims are what is said in labeling and advertising, and may be either of a positive (therapeutic or beneficial) or negative (lack of an adverse effect) nature. The positive or efficacy claims are not usually the direct concern of the toxicologist though it must be kept in mind that such claims both must be proved and can easily exceed the limits of the statutory definition of a device, turning the product into a drug or combination product. 

Once a Sponsor determines that their product fits one of the definitions of a combination product, the sponsor then must determine the lead Center within the FDA that will assume regulatory responsibility for the product. This determination is made by considering the primary mode of action (PMOA) [4] of the product. In simple terms, if the main function of the product is a device function, then it is likely that the Center for Devices and Radiological Health (CDRH) will have primary responsibility for the product. On the other hand, either the Center for Biologies Evaluation (CBER) or the Center for Drug Evaluation and Research (CDER) will be assigned primary review responsibility based on whether the PMOA of the product is dependent on... 

As noted above, a device may include a drug or biological component. The FDA provides a detailed definition of a combination product, the most general being ... 

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