美国医疗器械上市前监管概述与启示

美国食品和药物管理局(Food and Drug Administration,FDA)经过多年发展和改革,已形成了成熟的上市前监管体系。本文通过对FDA上市批准路径(上市前批准、上市前通告、人道主义用器械豁免)和申报流程进行系统介绍,总结了加强事前沟通、降低产品风险等级和设立实质审查程序三个方面的启示,希望我国监管机构能充分吸收美国FDA对于医疗器械监管的经验和教训,建立适合中国国情的医疗器械监管体系,确保公众用器械安全。

Overview and Enlightenment of Pre-marketing Supervision of American Medical Devices

After years of development and reform,the Food and Drug Administration(FDA)of the United States has formed a mature pre-marketing regulatory system.The FDA pre-market declaration path(pre-market approval,pre-market notification,humanitarian device exemption)and application process were systematically introduced in this article.Enlightenment from three aspects of strengthening prior communication,reducing product risk levels,and establishing a substantive review process were summarized.We hope that China’s regulatory agencies can fully absorb the US FDA’s experience and lessons in medical device supervision,and establish a regulatory system for medical devices suitable for China’s national conditions to ensure the safety of public devices.