美国FDA医疗器械监管科学研究项目简介(第二部分:有源医疗器械和计算机模拟)

目的： 通过介绍美国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：通过翻译和整理美国FDA发布的各类文件资料和研究项目，介绍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，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。在有源医疗器械领域，开展的研究项目有关于产品性能的研究，如电磁兼容性、磁共振成像安全、无线共存等；有计算机模拟和人工智能方面的研究，如人机交互、数字病理学评估、虚拟影像临床试验等；也有针对先进技术的研究，如患者生理信号监控技术、个性化心脏疗法等。

Introduction to the Research Project of US FDA Medical Device Regulatory Science (Part 2: Active Medical Devices and Computer Simulation)

Objective: To introduce the research projects of medical device regulatory science conducted by US FDA in order to provide references for the research of medical device regulatory science in China. Methods: Through the translation and collation of some documents and research project abstracts issued by FDA, the ongoing scientific research projects on regulation were introduced. Results and Conclusion: FDA cooperates with scientific institutions, clinical institutions, other government agencies and industry to carry out research on medical device regulatory science. The research results are used to ensure the safety and effectiveness of medical devices and promote the development of high-quality and innovative medical devices. In the field of active medical devices, the research projects include research on product performance, such as electromagnetic compatibility, magnetic resonance imaging security, wireless coexistence, etc., and research on computer simulation and artificial intelligence, such as human-computer interaction, digital pathological evaluation, virtual image clinical trial, etc. Researches on advanced technologies, such as patient monitoring technology, personalized heart therapy, etc., arealso involved.