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GUIDANCE DOCUMENT

Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes Guidance for Industry and Food and Drug Administration Staff November 2016

Final

Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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