FDA releases long-awaited guidance on 3D printed products

The FDA has issued new guidance on 3D printing for devices, medication and human tissue.

In a much-anticipated action, the FDA released its first-ever technical guidance for manufacturers using 3D-printed technology for medical products that include devices, medication and human tissue.

The guidance, which was based on a review of more than 100 marketed devices manufactured using the 3D-printing process, provides advice on technical aspects of 3D printing, also called “additive manufacturing.” Included in the devices studied by the agency were patient-matched products tailored to fit a patient’s anatomy, like knee replacements and implants designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction.

In its announcement the agency also clarified its informational recommendations for submissions of medical devices produced by 3D printing. The guidance is part of the agency’s effort to expedite approval and marketing of 3D-manufactured medical products, FDA Commissioner Scott Gottlieb, M.D., said in a statement.


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“Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality,” Gottlieb said in a statement. “We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.”

The new guidance clarifies FDA recommendations on what 3D manufacturers need to include with submissions as well as the agency’s thought process on “various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements.”

A recent example of an FDA-cleared 3D-printed device is Medicrea’s titanium interbody devices for spine surgery. The company’s IB3D suite of devices features Medicrea’s surgeon-adaptive technology, dubbed AdapTEK, which allows surgeons to design interbody devices according to individual specifications. Medicrea then creates the implants at its in-house additive manufacturing facilities.

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