On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,” which reconfirms its position on the importance of 3D printed medical devices. The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., the “3Rs”). In particular, the video posted by FDA, which is narrated by LT James Coburn, a senior research engineer at FDA, describes how scientists at the FDA are currently using 3D printers, as well as examples of 3D printed devices, including anatomical models and cranial replacement plates. FDA states that 3D printing devices undergo the same “high quality review that devices made through other methods go through.” FDA discusses its work with universities and the 3D printing industry to understand the technology, materials, and 3D printer itself, so it can evaluate safety and effectiveness of 3D printed devices. While the FDA mentions 3D bio-printing, it states that it is a long way off, but FDA is closely working with universities and others in the industry to foster innovation. Although the update and video are succinct, they help show that 3D printing is still on the FDA’s agenda and the agency is continuing to better understand this technology and its place in improving healthcare.
To learn more about the 3D printing of manufactured goods and medical devices, read our recent Reed Smith second edition 3D printing white paper: 3D Printing of Manufactured Goods: An Updated Analysis, as well as our first edition 3D printing white paper: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles.