law; bioprinting; additive manufacturing; 3D printing; Food and Drug Administration; medical product regulation; combination products; artificial organs; organ transplantation; Food, Drug, and Cosmetic Act; Public Health Service Act; National Organ Transplant Act


Each day, seventeen people die in the United States while waiting for an organ transplant. At least part of this need could be met by bioprinting, a technology that allows the on-demand production of custom-sized organs from a patient’s own cells. The field of bioprinting is progressing rapidly: the first bioprinted organs have already entered the clinic. Yet, developers of bioprinted organs face significant uncertainty as to how their potentially lifesaving products will be regulated—and by which government agency. Such regulatory uncertainty has the potential to decrease investment and stifle innovation in this promising technological field. This Note examines how the current framework for the regulation of medical products and human organs might be applied to bioprinted organs. This Note concludes that the existing regulatory schemes do not sufficiently address the specific regulatory needs created by bioprinted organs, which are uniquely interdisciplinary materials. Therefore, this Note proposes a new regulatory framework to reduce uncertainty for bioprinted organ developers and to promote patient access to these bioprinted materials that might soon serve as safe and effective replacements for donor organs.