As we have learned from Dr.Simon MDD1 (Medical Device Development 1) on WEEK 4 about combination product:
Definition of Combination Product
Primary mode of action = the single mode of action of a combination product that provides the most important therapeutic action of the combination product.
Includes two or more separate products packaged together
Includes products sold separately but intended for use with another type of product.

Dr.Simon mentioned that if you don’t know the product is a device or a drug, you will need to submit Request for Designation (RFD)
Companies may submit RFD outlining the rationale of the product as being a device, biologic, or drug
FDA responds to designate which center has lead responsibility based on primary mode of action
Decisions can be appealed to Ombudsman
Also, FDA,the Office of Combination Products (OCP), help to o classify medical products as drugs, devices, biological products or combination products and assign them to an FDA center for premarket review and regulation, where their classification or assignment is unclear or in dispute.
https://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm101496.htm#roles