FDA New Draft Guidance about Clinical considerations for IDES (Investigational Device Exemptions) for Neurological Devices Targeting Disease Progression and clinical outcomes

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FDA New Draft Guidance about Clinical considerations for IDES (Investigational Device Exemptions) for Neurological Devices Targeting Disease Progression and clinical outcomes

FDA developed this draft guidance to assist sponsors who intend to submit an investigational device exemption (IDE) to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centerd outcomes.

This new draft guidance is addressed to neurological medical devices that are designated to slow, stop or reverse the progression of disease.

It also provides general considerations for clinical trials that investigate neurological devices using biological markers.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM489111.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery