Lexology April 13, 2020
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,...
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