Additively manufactured medical products - the FDA perspective.
Additively manufactured medical products - the FDA perspective.
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DOI：
10.1186/s41205-016-0005-9
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发表时间：
2016-01-01
影响因子：
3.7
通讯作者：
Ricles, Laura
中科院分区：
文献类型：
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作者：
Di Prima, Matthew;Coburn, James;Ricles, Laura
医疗设备的增材制造/3D打印正变得越来越普遍，3D打印药物现已上市，生物打印正准备从实验室过渡到市场。尽管这些产品的技术多种多样，但美国食品和药物管理局（FDA）负责通过确保这些产品安全有效来保护和促进公众健康。为此，我们将介绍FDA目前对医疗产品增材制造/3D打印的看法，包括由器械和放射卫生中心（CDRH）、药物评价和研究中心（CDER）以及生物制品评价和研究中心（CBER）监管的医疗产品。每个中心都概述了各自领域的增材制造产品，以及在这些产品领域使用该技术的具体问题和想法。
Additive manufacturing/3D printing of medical devices is becoming more commonplace, a 3D printed drug is now commercially available, and bioprinting is poised to transition from laboratory to market. Despite the variety of technologies enabling these products, the US Food and Drug Administration (FDA) is charged with protecting and promoting the public health by ensuring these products are safe and effective. To that end, we are presenting the FDA's current perspective on additive manufacturing/3D printing of medical products ranging from those regulated by the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER). Each Center presents an overview of the additively manufactured products in their area and the specific concerns and thoughts on using this technology in those product spaces.