Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one another, don’t fit into traditional categories for medical products.

Combination products come in three basic configurations: Their constituent parts may be physically or chemically combined, co-packaged, or separately distributed with specific labeling that provides instructions for their combined use.

The different constituent parts of a combination product can add complexity to the final product. For example, when a medical device is part of the combination product, issues that relate to how the product is used can be as important as the product itself.

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