What types of marketing applications are required for a combination product?
Depending upon the type of combination product, its approval, clearance or licensure may be obtained through submission of a single marketing application, or through separate marketing applications for the individual constituent parts of the combination product. For most combination products, a single marketing application is sufficient for the product’s approval, clearance, or licensure. In some cases, however, a sponsor may choose to submit two marketing applications for a combination product when one application would suffice. For example, a sponsor may choose to submit two applications in order to receive some benefit that accrues only from approval under a particular type of application (e.g., new drug product exclusivity, orphan status, or proprietary data protection when two firms are involved). In other cases, FDA may determine that two marketing applications are necessary. For example, when one of the individual constituent parts of a combination product is already approved fo
