美国食品药品管理局（FDA）现代化法案要求所有从事生产、配制、传播、合成、组装、加工或进出口医疗器械的企业必须在FDA进行注册并同时递交美国代理信息。

FDA requires the firms that participate in manufacturing, distribution and other related activities of medical device for marketing in the United States to register the establishment annually and pay the registration fee. The establishments are required to complete annual registration between October 1 and December 31 each year.