“For medical devices, [3D printing, or additive manufacturing,] has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient’s own medical imaging,” the FDA writes. “Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches.”
The guidance covers two major areas: the design and manufacture of 3D printed medical devices, and testing for the devices. Although the FDA focuses on the benefits and promise of additive manufacturing, it also highlights a number of challenges carried with the technology related to device characterization and validation.
Read the full FDA guidance here.
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