Uncertain But Not Unregulated: Medical Product Regulation in the Light of Three-Dimensional Printed Medical Products.

As applications of three-dimensional (3D) printed medical products are being translated into clinical practice, stakeholders are increasingly concerned about whether current regulatory frameworks are able to regulate such products. With more additive manufacturing (AM) and 3D printed medical products being brought into clinical use and the assumption that usage will be more widespread in the future, a (perceived) lack of or inadequacy of regulation by some stakeholders is often depicted as a hindrance to the comprehensive translation of AM and 3D printed medical products into clinical use. This article addresses this uncertainty by analyzing existing medical product regulations and their applicability to AM and 3D printed medical products to assess the degree of regulatory oversight they administer.

A clarion call for understanding regulatory processes for additive manufacturing in the health sector.

Introduction: As Additive Manufacturing (AM) in the health sector evolves to the point where products can be translated into the clinic, these manufactured goods need to be assessed by regulators in order for such products to be manufactured, sold, and used in accordance with the law. In this article, the authors argue that if AM products in the health sector are to be regulated in the near future, stakeholders involved in translational research need to understand the challenges faced by both regulators and industry. We portray different points of possible dissonance for AM medical products with existing regulatory frameworks.