FDA Releases IDE Guidance on Neurological Device Trials
Abstract:The US FDA has issued final guidance intended to assist FDA staff and those in the healthcare industry with submitting investigational device exemption (IDE) applications to conduct clinical trials for neurological medical devices.
The guidance applies to medical devices designed to target the cause or progression of neurological diseases, such as Alzheimer’s disease, Parkinson’s disease, or primary dystonia. The final guidance offers general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments.
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