Department of Pathology and Laboratory Medicine, University of Louisville, Louisville, KY 40292, USA.
Clin Biochem. 2013 Oct;46(15):1320-2. doi: 10.1016/j.clinbiochem.2013.03.021. Epub 2013 Apr 8.
The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development.
美国医疗器械市场是全球最大的市场，2011 年销售额超过 1000 亿美元。尽管行业增长强劲，但需要提交 510(k) 或进行上市前批准 (PMA) 的中风险（II 类）和高风险设备（III 类）的 FDA 审批流程效率一直受到批评。最近，FDA 的设备和放射健康中心 (CDRH) 宣布成立医疗器械创新联盟 (MDIC)，这是一个公私合作伙伴关系 (PPP)，旨在共享监管科学方面的知识。总体目标包括为 FDA、行业和非营利实体之间的思想交流创建一个论坛；为关键工作组优先考虑的项目提案提供资金投资；并开发支持具有成本效益的创新、数据驱动方法和实施策略的工具。临床化学家临床实验室科学家有几个独特的机会为 MDIC 做出贡献。这些实验室专业人员拥有各种医疗器械实际性能的宝贵经验，他们的专业知识可以识别未满足的需求，并为加速设备开发做出贡献。
