Technical Considerations for Additive Manufactured Devices

Draft Guidance for Industry and Food and Drug Administration Staff

This guidance document is being distributed for comment purposes only.

FDA has developed this draft guidance to provide FDA’s initial thinking on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. Additive manufacturing (AM) is a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece. Rapid technological advancements and increased availability of AM fabrication equipment are encouraging increased investment in the technology and its increased use in medical devices. The purpose of this guidance is to outline technical considerations associated with AM processes, and recommendations for testing and characterization for devices that include at least one AM fabrication step.