摘要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。
Abstract：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.
塔娜，李思. 美国医疗器械上市前监管概述与启示[J]. 中国医疗设备, 2020, 35(3): 160-163.
TA Na, LI Si. Overview and Enlightenment of Pre-marketing Supervision of American Medical Devices. China Medical Devices, 2020, 35(3): 160-163.
