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BioWorld - Friday, January 16, 2026
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Home » Questions abound in FDA discussion paper for 3D POC manufacturing
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Questions abound in FDA discussion paper for 3D POC manufacturing

Dec. 13, 2021
By Mark McCarty
At long last, the FDA has released information on a potential regulatory framework for 3D device printing at the point of care (POC), just the first step in the implicit guidance development process. The document highlights several potential tripwires for device manufacturers and operators of health care facilities, but the large number of complex questions posed by the paper suggests that a final guidance is not likely to arrive any time soon.
BioWorld MedTech Regulatory 3D printing FDA

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