Did the FDA request prospective human clinical data for your 510(k) submission? If so, it’s time to read up on regulatory requirements for quality assurance in human clinical studies. Failure to understand these requirements could lead to the FDA rejecting your clinical results, serious compliance actions, and a substantial waste of time and resources.
This white paper provides insight into these requirements and breaks down the key elements of an effective, compliant clinical study. We’ll answer your biggest questions about quality assurance measures for one of the most significant (and expensive) endeavors you can undertake on the road to FDA clearance.
What you will learn in this 5-page white paper:
Get answers to all of these questions and more in this white paper.
Robert Seiple, RAC (US): 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
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