What is the FDA approval process for multiple component nanoproducts?
Current policy regarding combination products helps prevent duplication of effort and a protracted approval process. If the product meets the definition of a combination product (i.e., drug-device, drug-biologic, or device-biologic products), it will be assigned to an Agency center that will have primary jurisdiction for its regulation. The assignment of a “lead center” is based upon a determination of the “primary mode of action” (PMOA) of the combination product. For example, if the PMOA of a combination product is that of a biological product, then the combination product would be assigned to the Agency component responsible for premarket review of that biological product.
