How the FDA’s New 3-D Printing Guidance Informs Product Liability

Introduction

In December 2017, the Food and Drug Administration issued final guidance applicable to prescription drugs and medical devices manufactured with 3-D printing technology, or additive manufacturing (AM). The FDA’s recommendations are based on a review of 100 medical products made with AM that are currently on the market, as well as feedback from stakeholders in the AM industry. The recommendations follow draft guidance that the agency first promulgated in May 2016. In the words of FDA Commissioner Scott Gottlieb, the final guidance “provide[s] a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.” In a nutshell, ...