Draft Guidance for Industry and Food and Drug Administration Staff

By Global Compliance Seminar (LinkedIn Twitter)

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

Document issued on March 7, 2016

The U.S. Food and Drug Administration (FDA) recognizes the value of medical device innovation to address unmet clinical needs and improve patient care, particularly when novel treatments may revolutionize how we treat neurological diseases or conditions.

FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful to patients may represent a revolutionary option for patients.

FDA developed this draft guidance to assist sponsors, who intend to submit an investigational device exemption(IDE) to the FDA to conduct clinical trials on medical devices targeting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

This draft guidance is intended to apply to neurological medical devices that are designed to slow, stop, or reverse the progression of disease and result in clinically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This draft guidance provides general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome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

Download FDA Guidance in PDF

Download “IDEs for Neurological Devices” UCM489111.pdf – Downloaded 103 times – 147 KB

Last Updated: 2016-02-26

Clinical Considerations for IDEs for Neurological Devices