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Medical Devices / Regulatory Affairs

FDA Details Initial Thoughts on 3D-Printed Medical Devices

Dec. 8, 2017

The FDA has finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies outlining some of its initial thoughts on technical considerations.

From Stryker’s FDA clearance of its 3D-printed titanium interbody fusion cage to the first surgery performed in the U.S. with a 3D-printed implant manufactured by Australian devicemaker Anatomics, 3D-printing has continued to gain momentum in recent months.

The FDA has approved marketing applications for more than 100 3D-printed medical devices and this is “likely just the tip of the iceberg given the exponential growth of innovative research in this field,” said FDA Commissioner Scott Gottlieb.

According to Gottlieb, the agency is now preparing for “a significant wave of new technologies that are nearly certain to transform medical practice,” and it is working to provide a more comprehensive regulatory pathway that keeps pace with the advances.

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