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GUIDANCE DOCUMENT

Technical Considerations for Additive Manufactured Medical Devices Guidance for Industry and Food and Drug Administration Staff December 2017

Final
Docket Number:
FDA-2016-D-1210
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

FDA has developed this guidance to provide the Agency’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 sequentially building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly produce alternative 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 by the medical device industry. 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 additively manufactured component or additively fabricated step.


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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1210.