Is the product a combination product (i.e., a product comprised ofboth a drug and a device, a device and a biological product, or a drug anda biological product)?
As discussed above at question 9, a combinationproduct is assigned based on its PMOA to an Agency Center or alternativeorganizational component that will have primary jurisdiction for its premarketreview and regulation. For example, if the PMOA of a device-biological combinationproduct is attributable to the biological product, the Agency component responsiblefor premarket review of that biological product would have primary jurisdictionfor the combination product.
Related Questions
- I believe my combination product may qualify for designation as an orphan drug or biological product, or as a humanitarian use device. Where can I find information about orphan product regulation?
- Is the product a combination product (i.e., a product comprised ofboth a drug and a device, a device and a biological product, or a drug anda biological product)?
- Does a veterinary drug/medical device combination require an AIF-NDS?
