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Fda has developed this guidance to provide the agency’s initial thinking on technical considerations specific to devices using additive manufacturing, the broad category. Process monitoring techniques, and acceptance testing criteria may differ from other manufacturing techniques • starting material is altered to create final material Overall, the fda is approaching 3d printing/additive manufacturing (am) for medical devices using previously established processes for medical devices 12/4付で米国FDAから「Technical Considerations for Additive Manufactured Medical Devices」と題する、 企業及びスタッフ向け最終ガイダンスが発出されています。 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. Fda regulatory pathways and 10 technical considerations for the 3d printing of medical models and devices While the workshop served as an important starting point in the discussion on the technical considerations of additive manufacturing of medical devices, the fda’s efforts have. The following questions pertain to all stages of medical device development using additive manufacturing (am) Collectively, they helped to inform the content of the workshop, were. This talk will discuss the broad medical applications that makes am attractive to medical devices along with the applicability of the different am technologies to the medical. Fda has developed this leapfrog guidance to provide fda's initial thoughts on technical considerations specific to devices using additive manufacturing (am), the broad. In 2016, the fda issued draft guidance on the technical considerations for additive manufactured devices to advise manufacturers who are producing devices through 3d printing.