February 2015

White Paper: Combination Products: A 40 Year Regulatory Evolution

Since the first combination products came under the Food & Drug Administration’s purview over 40 years ago, the FDA has taken various actions to organize, delegate and outline how it will regulate the manufacture and distribution of these products in the U.S. This white paper from NSF International discusses challenges presented by the FDA’s impending release of guidance on human factors for combination products, adverse event reporting and other documents that may impact combination products.