Are you ready to sell your medical devices in the United States? Before you enter the US market, you need clearance from the US Food and Drug Administration, which means you probably need to submit a 510(k).
510(k) submissions, also known as Pre-Market Notifications, are required by the FDA for a range of medical device types and classifications. 510(k)s have unique content and format requirements – they are not identical to a European Technical File. And, the FDA's recent changes to 510(k) requirements make the submission process more rigid than ever. In this white paper, we will address your biggest questions about submitting a 510(k) in today’s market. What you will learn in this 10-page white paper:
We answer all of these questions and many more in this whitepaper.
Robert Seiple, RAC (US): Robert Seiple is Senior Regulatory Consultant at Emergo. He has over 35 years of experience with quality assurance and regulatory affairs in regulated industries, including medical devices, pharmaceuticals, and clinical research. His areas of expertise include 510(k) submissions, CE Marking, quality system implementation, training, and auditing.
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
阅读更多为了获得澳大利亚市场准入,医疗器械和体外诊断(IVD)器械制造商需要将他们的产品列入由药品管理局(TGA)监管的澳大利亚医疗用品登记表(ARTG)。
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