Every year Emergo examines published data on medical devices cleared by the US Food and Drug Administration (FDA). The 15,000+ device clearances we analyzed in March 2017 went through the FDA’s Premarket Notification program, known as the 510(k) process. Technically, the FDA does not “approve” devices; they clear them for sale in the US. The 510(k) process applies to nearly all Class 2 devices, and less than 10% of Class 1 devices. We sorted all devices based on the date they were cleared by FDA, not the date they were submitted. Want to see average review time for YOUR specific device? Be sure to try our FDA 510(k) calculator (opens new window) which shows the historical average review times for specific devices cleared by FDA during the last five years.
Some highlights from the March 2017 analysis:
PDF also shows data from 2012, 2013, 2014 and 2015, plus data back to 1976!
PDF also shows five year trend plus timeframes for Special and Abbreviated
PDF also shows how many get cleared by FDA within 6, 9 and 12 months
PDF also shows how long it takes to get approval for 15 other device categories.
PDF also shows many other countries and trend in their submissions over time.
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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