含纳米结构材料的医疗器械 FDA 批准状况报告。
A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials.
机构信息
Chemical Engineering, Northeastern University, 360 Huntington Avenue, Boston, MA 02115, USA; Mechanical & Industrial Engineering, Northeastern University, 360 Huntington Avenue, Boston, MA 02115, USA. Electronic address: https://twitter.com/@aandrewdjones.
Chemical Engineering, Northeastern University, 360 Huntington Avenue, Boston, MA 02115, USA.
出版信息
Trends Biotechnol. 2019 Feb;37(2):117-120. doi: 10.1016/j.tibtech.2018.06.003. Epub 2018 Jul 31.
Commercialization has been slow since the FDA approved a medical device containing nanomaterials in 1980. In 2017, the FDA released draft guidance to accelerate approval. We highlight here that geographical and structural separation of researchers, manufacturers, and clinical servicers may slow commercialization more than FDA approval.
自 1980 年 FDA 批准含有纳米材料的医疗器械以来，商业化进程一直较为缓慢。2017 年，FDA 发布了加速审批的指导草案。在这里我们强调，研究人员、制造商和临床服务提供商之间的地域和结构上的分离可能会比 FDA 批准更能减缓商业化进程。
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