Onl Y the U.S. has defined combination products by law, as this video explains. According to the Food and Drug Administration, a combination product refers to a therapeutic or diagnostic item combining medical devices, drugs, and/or biological products. Common examples of combination products include a preloaded EpiPen, a first aid kit, and a transdermal patch.
Typically, one agency oversees a product’s development, but when developing a combination product, more than one agency’s regulations govern development and testing. This complexity in compliance leads many companies to hire a combination product services contractor that guides the development and ensures compliance with all regulations. For example, the combination product services contractor assists the company with its Pre-Request for Designation (Pre-RFD) and Request for Designation (RFD), among other FDA-required applications. If the combination product introduces a new drug or device, the developing company may also need the assistance of the contractor to complete the investigational new drug application (IND) or investigational device exemption application (IDE), whichever applies.
Other countries have not passed laws defining or regulating combination products. They use guidelines developed by their relevant government agencies. Developing a combination product to market in multiple countries means meeting the criteria of each country’s guidelines.