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Though the FDA has approved more than 85 applications related to 3D-printed medical devices, the organization is still working to issue broader regulations that will streamline the application process. All applications approved so far have been limited to lower-risk devices, such as non-load-bearing implants.

This draft guidance, developed as the result of a 2014 dialogue surrounding the technology, is meant to help device manufacturers understand the FDA’s initial thoughts on 3D printing, while the organization is still working to finalize regulations.
So far, the FDA is regulating 3D-printed medical devices from two standpoints: design and manufacturing, as well as testing. In order to validate the many 3D printing processes used to make medical devices, the FDA instructs manufacturers to “clearly identify each step in the printing process… from the initial device design to the post-processing of the final device,” as well as understand how each of these steps might affect the ultimate product.

In terms of the designs for medical devices for both patient-specific and standard products, the FDA urges manufacturers to outline important parameters, such as the “desired feature sizes of [a] final finished device” and how clinical imaging (CT scans, MRIs, etc.) might affect the outcome of a design for patient-specific items. How software is used to create devices, including file conversions, use of support material, slicing and other variables are important inclusions in a company’s FDA approval application.

Naturally, in seeking FDA approval, the materials that make up medical devices must be described. This includes how an additive manufacturing process might affect the final product, as well as the qualities of any recycled material that might be used to 3D-print subsequent items. The post-processing required for 3D-printed objects must also be carefully described.

The FDA’s overall criteria for testing 3D-printed medical devices are similar to those associated with traditionally manufactured medical devices. Mechanical testing, such as material and performance qualities, should be performed; however, in 3D printing, factors like the orientation of an object as it is printed must be listed as a test variable.