Di Prima Matthew, Coburn James, Hwang David, Kelly Jennifer, Khairuzzaman Akm, Ricles Laura
US Food and Drug Administration, Center for Device and Radiological Health, Silver Spring, MD 20993, USA.
US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, USA.
3D Print Med. 2016;2. doi: 10.1186/s41205-016-0005-9. Epub 2016 May 18.
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.
医疗设备的增材制造/3D打印正变得越来越普遍，一种3D打印药物现已上市，生物打印也准备从实验室走向市场。尽管有多种技术可实现这些产品，但美国食品药品监督管理局（FDA）负责通过确保这些产品的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，这些产品涵盖了由器械与放射健康中心（CDRH）、药品评估与研究中心（CDER）和生物制品评估与研究中心（CBER）监管的产品。每个中心都概述了其领域内增材制造产品的情况，以及在这些产品领域使用该技术的具体关注点和想法。
