FDA Webinar Debrief : Neurological Devices – Drug and Device Digest




Key Takehomes
– New Division
– Design studies based on Indication for Use and Label claims
– Time studies based on your product roadmap
–  Keep documentation and assess impact of product design changes
– IRBs can be a helpful resource for IDE waivers
– Early Feasibility Studies (EFS) encouraged for streamlined development
– Several options of getting in touch directly with Division


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