The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and ventilators abound, making 3D printing particularly interesting with regard to fighting COVID-19. The FDA even issued some guidance on 3D printing of medical devices, accessories, components and parts during the COVID-19 pandemic. But potential exposure to patent infringement liability remains a risk.
FDA Guidance Addressing 3D Printing
The FDA began addressing the 3D printing of medical devices years ago. For example, in October 2014, the FDA held a public workshop, “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Then, in December 2017, the FDA issued “Technical Considerations for Additive Manufactured Medical Devices Guidance for Industry,” which addressed the 3D printing of medical devices. According to the FDA, “Additive manufacturing is a process that builds an object by sequentially building 2-dimensional layers and joining each to the layer below, allowing device manufacturers to rapidly produce alternative designs without the need for retooling and to create complex devices built as a single piece.” Additive manufacturing is the process of 3D printing. In the guidance, the FDA discusses design and manufacturing process considerations, device testing considerations, and labeling for the emerging technology of 3D printing medical devices.