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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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.