Comment   |   Volume 166, Issue 2

FDA Regulation of 3D‐Printed Organs and Associated Ethical Challenges

166 U. Pa. L. Rev. 515 (2018)

January 2018

The implications of pervasive implementation of 3D printing with biological material, also known as “bioprinting,” are vast. They present never‐before‐seen hurdles, which are particularly complicated due to the vulnerability of the patients, who often need new organs to survive, involved. In this Comment, I limit the scope of this inquiry to the most immediate challenges of embracing 3D‐printed organs in our health care market: potential statutory roadblocks, regulatory concerns over manufactured organs, and ethical challenges of which we must remain aware. I submit one path by which 3D‐printed organs can fit in our current legal and regulatory framework. I also define who should be charged with regulating them and propose how future regulators should do so. Finally, I raise additional concerns of 3D‐printed organs that will require deeper analysis as more information becomes available, including the myriad ethical challenges presented by this new technology.

The U.S. Food and Drug Administration (FDA) is the appropriate body to regulate 3D‐printed organs because a manufactured organ must be treated differently than a human organ, which can be transplanted as “simply” part of the practice of medicine. It remains to be seen how the FDA will gather sufficient data to satisfy premarket approval requirements, determine who gets access and when, and how to govern the marketing of 3D‐printed organs because the output is individualized. But the process by which the organs are created can be scaled dramatically. In so doing, those in charge must also confront unique, multifaceted ethical challenges.

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