The U.S. Food & Drug Administration recently published "Technical Considerations for Additive Manufactured Medical Devices," a guidance document for industry and the FDA staff and said it is the world's first agency to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.

The document, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf, addresses a range of issues, from design, software, and materials (both starting materials and reuse of materials) to post-processing, device testing, biocompatibility, and labeling.

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