CDRH Industry: FDA Final Guidance on IDEs for Neurological Devices Targeting Disease Progression and Clinical Outcomes

On November 7, 2016, the FDA published the final guidance “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” This final guidance is intended to aid Industry and FDA staff in determining the types of data that may be needed to support an IDE application and design of clinical trials for a neurological medical device. The final guidance includes considerations for the research and development of these devices, as well as FDA review considerations to potentially streamline the process to bring new treatments for progressive neurological diseases to the U.S. market.

Medical devices intended to slow, stop, or reverse the effects of neurological disease may face several challenges with regard to collecting safety and efficacy data in a clinical study. Especially when less invasive pharmacotherapy approaches may be better understood in the clinical community. This final guidance assists Industry and FDA staff in considering the benefits and risks of  medical devices that target either the cause or progression of a neurological disorder such as Alzheimers, Parkinson’s or Primary Dystonia, rather than their symptoms, and address an unmet public health need.

We recommend that you use this document to help determine the types of data that may be needed to support an IDE application and to help in the design of clinical trials. The clinical considerations mentioned in the guidance represent FDA’s thinking based on the information available at this time. For this reason, we strongly suggest that sponsors who wish to conduct such studies submit a Pre-Submission to facilitate discussion of pre-clinical test protocols, clinical trial designs, and proposed indications for use.

Visit the IDE Approval Process webpage for information about the IDE regulation.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health