美国FDA医疗器械监管科学研究项目简介(第一部分:无源医疗器械)

A Brief Introduction to Scientific Research Project of Medical Device Regulation by FDA(Part 1: Passive Medical Devices)

目的:介绍美国FDA开展的医疗器械监管科学研究项目,为我国医疗器械监管科学研究提供参考。方法:翻译和整理美国FDA发布的各类文件资料和研究项目摘要,梳理其正在开展的监管科学研究项目。结果与结论:美国FDA与科研机构、临床机构、其他政府机构及产业界合作开展医疗器械监管科学研究。依据临床需求和前沿研究,在骨科、心血管科、放射学、微生物学等多个领域开展专题研究,取得的研究成果用于确保医疗器械的安全性和有效性,并促进医疗器械企业创新和高质量发展。其中在无源医疗器械领域开展的研究项目有关于产品性能及检测方法的研究,如物理机械性能研究、流体性能研究、病原菌快速检测技术等;有针对新兴技术的研究,如增材制造、新型材料与制造的研究;也有关于医疗器械安全和有效性的基础性研究,如纳米毒理学、聚合物动力学、微生物学等研究。

Objective: To introduce the scientific research project of medical device regulation by Food and Drug Administration(FDA) in order to provide references for the scientific researches of medical device regulation in China. Methods: Various documents and research project abstracts issued by FDA were translated and sorted out and the regulatory science research projects undergoing were reviewed. Results and Conclusion: FDA cooperates with scientific institutions, clinical institutions, other government agencies and industries to carry out scientific researches of medical device regulation. Based on current clinical needs and cutting-edge researches, FDA conducts special researches in such fields as orthopedics, cardiology, radiology and microbiology. The research results are used to ensure the safety and effectiveness of medical devices and promote high development and innovation of medical device companies. In the field of passive medical devices, the current research projects include researches on product properties and detection methods, such as physical and mechanical properties, fluid properties, rapid detection technology of pathogens, etc. They also include researches on emerging technologies, such as additive material manufacturing and new materials and their manufacturing. There are also basic researches on the safety and effectiveness of medical devices, such as nanotoxicology, polymer dynamics, microbiology, etc.