美国FDA医疗器械监管科学研究项目简介(第三部分:医学影像和光学器械)

目的:通过介绍美国FDA开展的医疗器械监管科学研究项目,希望为我国的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摘要,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...

A Brief Introduction to Scientific Research Project on FDA Medical Device Regulation (Part 3: Medical Imaging and Optical Device)

Objective: To introduce the scientific research project on FDA medical device regulation in order to provide references for the scientific research of medical device regulation in China. Methods: Through the translation and collation of various documents and abstracts of research projects issued by FDA, the ongoing scientific research projects on regulation in America were introduced. Results and Conclusion: FDA has cooperated with scientific institutions, clinical institutions, other government agencies and industries to carry out researches on medical device regulation. The scientific research achievements are used to ensure the safety and effectiveness of medical devices, and to promote the high-quality development and innovation of medical device enterprises. In the field of medical imaging and optical device, the current research projects include researches on the imaging quality of medical images(dose image quality evaluation, imaging color performance test, etc.) and researches on the application of new imaging technologies(functional magnetic resonance imaging, spectral imaging, high-resolution optical imaging, etc.). They also include innovative application research on medical imaging technology such as 3D breast imaging, computer-aided diagnosis and so on.