ABSTRACT
In the United States, the term “combination product” refers to a product comprising any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product (21 CFR 3.2; see 21 USC 353(g)). Types of combination products include physically or chemically combined products (such as drug-eluting stents or syringes marketed prefilled with a drug or biological product); co-packaged products (such as an ampule of a drug packaged together with a delivery device, first aid kits that include bandages and drugs to treat wounds and other injuries, or surgical kits that include devices and drugs that might be used for a particular type of surgical procedure); and certain separately marketed but “cross-labeled” products (such as a laser and a light-activated drug that are marketed separately from one another but labeled specifically for use with one another). See 21 CFR 3.2(e).
