A combination product is a product composed of any combination of a drug and a device; biological product and a device; a drug and a biological product ;or a drug, device, and a biological product. Two or more separate products packaged together in a single package. Combination product are assigned to a FDA center that will have primary jurisdiction for it is premarket review and regulation to evaluate the safety and effectiveness of class III medical devices.
Combination products are a combination of two or more regulated components like drug-device, device-biologic, drug-device-biologic etc. It is a combination of drugs, biological products and devices which is sometimes, difficult to judge as which category it belongs to like CDRH, CDER and CBER. Hence FDA designates which would be having responsibility based on primary mode of action. Jurisdiction determines the FDA centre that will regulate the product. Combination products are sold separately but intended for use with another product.
It was mentioned that the FDA designates the primary mode of action, however from my understanding I didn't think this was a requirement. It seemed to be more of an option to use the FDA for designation through a Request for Designation (RFD). For example, if there were disagreements within a company about the designation or if a company was just unsure of the best designation, they have the option to submit the RFD and outline the rationale of their product and then the FDA would decide on the designation.
Combination products include device, drugs, device biologic etc and jurisdiction of the FDA to determine which category they line in as they are responsible for primary review before it is released in market
I agree to the previous posts that Jurisdiction of combination drugs is determined by their primary mode of action- “the single mode of action of a combination product that provides the most important therapeutic action of the combination product” but there are some cases where there are more than one therapeutic action. When such a case arises, FDA has a algorithm and procedures set to determine the centre assignment which will be based on the product's safety and efficacy.
Something I would like to introduce to the discussion is the complexity of post-market surveillance and regulation for combination products. Contrasting standalone products (e.g., devices/drugs), combination products have unique challenges for regulation, especially if one component (e.g., biologics) is working well while the other component (e.g., delivery device) is not. For example, if an auto-injector insulin pen was approved with CBER, but then the injector device started to fail while the insulin formulation has positive responses, then it becomes hard to coordinate recalls/regulations.
The FDA's Office of Combination Products (OCP) does step in to coordinate CDER, CDRH, and CBER's involvement at times like this as well as to support safety and efficacy overall, but overlapping jurisdictions can make monitoring and combination recalls difficult. That is why it is critical to thoroughly foresee problems from all sides (e.g., biologics and device side in the aforementioned example) while fabricating and validating therapy function.
Based on this discussion, I wonder if there would be ways to tweak the current model of oversight the FDA has to bolster the effectiveness of monitoring and the regulating of combination therapies? Should there be separate, specialized sub-divisions to manage combination therapies?
