Can Regulation be as Innovative as Science and Technology? The FDA's Regulation of Combination Products

The twentieth century witnessed significant and continuous advances in medical product innovation, with breakthroughs in pharmaceutical, engineering and bioscience fields that revolutionized health care services. However, with innovation comes potential risk. Congress has been concerned about risks associated with medical products since the early 1900s,1 and has, over time, empowered the U.S. Food and Drug Administration (FDA) to ensure that new medical products meet evolving standards of safety and effectiveness. The Food, Drug, and Cosmetic Act (FDCA) has been amended numerous times since the early 1900s, often in reaction to both perceived and real risks associated with new medical products.2 The result is a complex regulatory apparatus that administers a variety of legislative mandates specifically tailored to the unique features of drugs, medical devices and biologics. In recent years, scientific and technological advances in the fields of tissue engineering, cell biology, gene therapy and materials science, to name a few, promise breakthroughs that