Various scientific and technological advances have led to an increased demand for FDA combination products. These products require special regulation guidelines due to their legal complexity. Here’s an overview of what FDA combination products are from a legal standpoint.

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Combination products are defined in different ways in different countries. As of now, the US is currently the only nation that has a legal definition for this term, with other countries outlining these products in guidance documents. The regulations set by the FDA state that the definition of combination products applies only to combinations of drugs, devices, and biological products. This law does not redefine what a drug, a device, or a biological product is; it only states that a combination product is a combination of two or more of these items in different categories.

Combinations of two drugs, two devices, or two biological products are not considered to be combination products. Although the FDA does provide guidelines for combination drugs, these do not qualify as combination products because they are not regulated by two different centers.

For more information on combination products and how they are regulated, please read the FDA’s guidelines for yourself. You can read all about combination products on the official FDA website.


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