TheAmerican Banknote Corporation（abcorp）宣布了其卓越中心的注册U.S. Food and Drug Administration(FDA).
ABCorp’s Additive Manufacturing Center (AMC) is said to be packed with the MJF and binder jet systems needed, to engage in prototyping and ‘bespoke production’ applications. Effectively, having been registered with the FDA, the site is now green-lit to offer services to medical manufacturers on a wider scale, providing them with a potential means of reducing their products’ times-to-market.
ABCorp’s expanding horizons
Abcorp的印刷根可以追溯到1795年的编队，当时它是由新成立的美国第一银行（美国第一银行）的任务，并为当时的年轻美国创造了伪造的货币。从那以后，该公司继续开发广泛的产品和服务组合，以促进全球交易。
Continuing its focus on payment security to this day, ABCorp’s offering now revolves around the manufacture and personalization of contactless credit cards, as well as short-run 3D printing services. In addition to part production, the company also offers to help clients in the automotive, aerospace, consumer, and robotics sectors achieve their design, engineering, scanning, and reverse engineering goals.
在过去的一年中，Abcorp继续扩大其能力，以此作为更好地满足这些用户需求的一种手段，首先安装解决方案C500轻扫描仪和Girbau Dy130零件垂死单元，然后acquiring Desktop Metal’s Shop System.
In terms of printed part compliance, the organization has also amassed a long list of certifications, includingISO,Intergraf,HITRUSTandPCI认证涵盖了从产品标准，安全和风险管理到信用卡生产的问题，现在可以将FDA注册添加到已经令人印象深刻的监管收集中。
Opening new medical avenues
Based in Boston, ABCorp’s 125,000 square foot AMC was refurbished as recently as November 2021, and now features a number of cutting-edge 3D printing technologies. Amongst these, the facility is known to be fitted with生命值Jet Fusion 5210and full-color capable Jet Fusion 580 3D printers, as well as桌面金属Production SystemandAMT’sPostpro3dsmoothing machines.
在材料方面，这意味着AMC的工程师还能够从HP的3D高可重复性PA 11，PA 12，CB PA12和PP聚合物中生产零件BASF’sUltrasint TPU01, and the 174PH and 316L stainless steels.
实际上，ABCORP不断增长的3D打印功能已经使其能够开始为客户提供全彩色原型制作，短期零件生产，工业垂死和后处理服务。但是，医疗行业的高管制性质意味着需要在特定条件下生产临床设备，这可以阻止供应商进入有利可图的市场。
With this in mind, the company has now registered its AMC as an FDA manufacturing facility, allowing it to provide services to all major medical device production firms handlingClass I, II, and some Class IIIproducts.
Following the move, ABCorp has therefore become able to produce everything from devices deemed likely to present minimal potential for harm, right up to a limited number of implants, but for now, the firm continues to market its services as a prototyping and low volume production tool, that enables users to “obtain superior medical devices, achieve a faster ‘go-to-market’ and realize a lower cost structure.”
“ABCorp历史追溯到225多年,箴言iding essential critical goods & services to world-class companies and federal, state, and local government agencies,” said Neil Glazebrook, VP of 3D Solutions at ABCorp. “Additive manufacturing, including 3D printing, offers our clients complete design freedom and is nothing less than transformative for the medical device industry.”
FDA的最重要批准
当涉及到美国的3D印刷医疗设备时，制造商必须首先确保它们符合FDA的状态，并且获得该机构的批准通常被视为迈向其商业化的重要一步。
In July 2021, for instance,桌面健康acquired the rights to Phonograft 3D bioprinting, a technology that its creators are currentlyseeking 510K FDA clearancefor. The process is designed to yield soft tissues that expedite the regeneration of the human eardrum, and it’s believed to have future potential cardiovascular and neuronal applications as well.
It’s not just US-based firms seeking FDA accreditation either, as Chinese pharmaceutical firmTriastekalso gained Investigational New Drug (IND) approval from the agency last year. The certification was awarded to itsfirst 3D printed drug product，T19，一种专门为在预设周期中为类风湿关节炎提供药物的系统。
More recently, the FDA itself has发出反馈意见在新的监管框架上，它正在创建，以确保3D印刷医疗设备的持续质量。该组织没有作为指导，而是希望其最初discussion paper产生行业专家的回应，然后可以用来塑造未来的法规。
要了解最新的3D印刷新闻，请不要忘记订阅3D打印行业newsletter或跟随我们推特或喜欢我们的页面Facebook.
For a deeper dive into additive manufacturing, you can now subscribe to ourYouTube频道，包括讨论，汇报和3D打印进程的镜头。
Are you looking for a job in the additive manufacturing industry? Visit3D Printing Jobsfor a selection of roles in the industry.
Featured image shows a sign outside the FDA’s headquarters. Photo via the University of Oxford.
