Docket Number:
FDA-2016-D-0539
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to apply to neurological medical devices that are designed to slow, stop, or reverse the progression of disease and result in clinically meaningful patient outcomes. This guidance provides general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments.

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All written comments should be identified with this document's docket number: FDA-2016-D-0539.