FDA Introductory Seminar on Navigating the Regulatory Landscape for Neurological Devices and Moving Neurotechnologies to Patients and Caregivers

Event Time: Thursday April 26, 2018 12:15 pm to 12:45 pm
ELA Type: Research Corner
Topic(s): Research Methodology, Education, and History
Director(s): Katrina Gwinn MD, FAAN
Description: Treatment of neurological conditions is increasingly dependent on medical devices, from deep brain stimulation devices to neurothrombectomy devices. Clinical studies utilizing these significant risk medical devices generally require FDA review prior to being initiated in the United States. As part of FDA ongoing efforts to facilitate this research in the US, the median review time for investigational device exemptions (IDE) have decreased over the past six years from approximately over 400 days to 30 days. What has changed at the FDA to reduce its IDE review rates? What goes into an IDE application? What is a Q-sub? Should Principal Investigators submit a Q sub before submitting the IDE? What constitutes a significant risk device? Are there any exceptions? What is an early feasibility, traditional or pivotal trial? For neurological devices we will address these and other questions to make the regulatory landscape for neurological devices more transparent and predictable. There will be time for a question and answer period at the end of the session.
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CME Credits: 0
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