Uncertain But Not Unregulated: Medical Product Regulation in the Light of Three-Dimensional Printed Medical Products
Antonia Horst, Fiona McDonald
Abstract
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. It concludes that there are specific legal questions that need to be clarified, but the products are not expected to "disrupt" existing legal frameworks.