Here are five things to know:
1. The draft guidance outlines considerations for design and manufacturing, touching on quality system requirements and device testing considerations.
2. The FDA offers advice on device design, software workflow, material controls, post-processing, quality data and process validation and acceptance activities.
3. The device testing section offers insight on device descriptions, mechanical testing, dimensional measurements, material characterizations, cleaning, biocompatibility and labeling considerations.
4. The FDA will welcome comments on the guidance until Aug. 8, 2016.
5. The agency has cleared more than 85 three-dimensional printed device applications.
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