The US remains the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission, what the FDA wants to see, and how to avoid problems that delay or derail submissions. In this webinar recorded in July 2017, we cover:
DOWNLOAD PDF OF FDA 510(K) WEBINAR SLIDES (opens new window)
Audrey Swearingen is Director of Regulatory Affairs at Emergo's Austin, Texas headquarters. With over 20 years of experience in regulatory affairs, Audrey's areas of expertise include US FDA, European and Canadian medical device registration.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多近年来,全球医疗法规监管日新月异,各国、各地区监管机构纷纷出台、变更当地法规。与此同时,作为全球第一大医疗器械市场的美国,在其法规领域也做出诸多变化。这给不少以上市美国市场为目标的医疗器械企业及制造商带来了不小的挑战。 对此,Emergo by UL法规专家团队准备举办一场线上研
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