Combination Products: A 40 Year Regulatory Evolution

ABSTRACT

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 (FDA) medical product centers. Since the first combination products came under the FDA’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. and on July 22, 2013, issued a Final Rule entitled, “Current Good Manufacturing Practice Requirements for Combination Products” (21 CFR Part 4). However, over the past year, FDA has taken enforcement action with specific reference to 21 CFR Part 4, providing insight into how the regulation of combination products will look in this ever expanding product space. On January 27, 2015, the Agency released a draft guidance document entitled, “Current Good Manufacturing Practice Requirements for Combination Products” to accompany the Final Rule. Over the coming year, FDA is also expected to release guidance on human factors for combination products, adverse event reporting and other documents that may impact combination products. Moreover, there are particular regulatory challenges that face traditional pharmaceutical and medical device companies when manufacturing or distributing combination products in the U.S. This document discusses these challenges and how industry can prepare to meet them.

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