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Combination Products: A 40 Year Regulatory Evolution

Technological advances in healthcare products and the delivery of those products will continue to straddle the traditional boundaries of regulatory authority between the U.S. Food and Drug Administration’s (hereafter referred to as FDA or the Agency) medical product centers. Since the first combination products came under the FDA’s purview over 40 years ago, the Agency has taken various actions to organize, delegate, and outline how it will regulate the manufacture and distribution of these products in the U.S.

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