Companies who market a combination product in the US face specific challenges to get and keep their products regulatory compliant. Although no new requirements are added, the scope for conforming with the requirements is changed considerable.
FDA introduced current good manufacturing practice (cGMP) requirements for combination products. A combination product is a combination of two or three different types of the following regulated products: a biological product, a drug, a medical device. FDA recognizes four types of combination products: single entity, co-packaged, cross-labelled, (investigational) cross-labelled.
There are two ways to conform with the regulations:
Ensure conformity of the combination product by applying all cGMP regulations applicable to each of the parts, OR by only applying the cGMP regulations of one of the parts.
However manufacturers must ensure the following: If parts - drug, biologic, device, HCT/Ps - are combined in a combination product, each individual part keeps its own cGMP requirements for conformance! If any conflict or ambiguity appears, you follow the most specifically applicable regulation.