Min Yue, Liu Bin. Study of Regulatory Requirements of Customized Device in the U.S.[J]. Chinese Journal of Medical Instrumentation, 2017, 41(1): 43-47. DOI: 10.3969/j.issn.1671-7104.2017.01.012
      Citation: Min Yue, Liu Bin. Study of Regulatory Requirements of Customized Device in the U.S.[J]. Chinese Journal of Medical Instrumentation, 2017, 41(1): 43-47. DOI: 10.3969/j.issn.1671-7104.2017.01.012

      Study of Regulatory Requirements of Customized Device in the U.S.

      • This article introduces the regulatory requirements of customized device in the U.S. And it also proposes suggestion and reference through comparative study on relationship among customized device, humanitarian use device and 3D printing device, and on similarities and differences of American regulatory requirements between customized device, and humanitarian used device.
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