A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes
A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes
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DOI：
10.2217/rme.15.52
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发表时间：
2015-01-01
影响因子：
2.7
通讯作者：
Williams, David J.
中科院分区：
文献类型：
--
作者：
Hourd, Paul;Medcalf, Nicholas;Williams, David J.
用于组织和器官功能修复的定制3D功能性活体结构的计算机辅助3D打印工业生产方法面临着重大的监管挑战。使用定制的3d生物打印鼻植入物的制造作为一个知情但假设的例子，我们研究如何监管这些产品。现有的欧盟和美国监管框架没有考虑到3D打印与传统制造方法之间的差异，也没有考虑到使用机械化而不是手工方法创建个性化定制产品的能力。已经受到广泛的监管控制，与计算机辅助设计到制造过程的控制以及相关软件系统链相关的问题给这些复杂的3d生物打印先进组合产品的制造商带来了额外的科学和监管挑战。
Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.