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# FDA Draft Guide on Neurological Device IDEs
- URL: https://www.fdaweb.com/fda-draft-guide-on-neurological-device-ides/
- Published: 2016-03-04T12:00:00.000Z
- Updated: 2026-09-15T02:40:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134968

> FDA has posted a draft guidance on “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes” to assist sponsors in evaluating the benefits and risks of devices that target either the cause or progression of a neurological disorder or condition such as Alzheimer’s disease, Parkinson’s disease, or primary dystonia, rather than their symptoms. FDA says it 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. The document provides considerations for the research and development of such devices, as well as FDA review considerations to advance this innovative technology sector of technology.