CDRH Industry: FDA Issues Draft Guidance on IDEs for Neurological Devices Targeting Disease Progression and Clinical Outcomes

Today the FDA issued draft guidance “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” This leapfrog 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 FDA issues leap frog guidances to provide initial recommendations for emerging medical device technologies that address an unmet medical need and improve patient care, such as those used to treat progressive neurological diseases.

The draft guidance is intended to assist Industry and FDA staff in considering the benefits and risks of medical devices that target either the cause or progression of a disorder such as Alzheimers, Parkinson’s or Primary Dystonia, rather than their symptoms. The draft guidance also provides considerations for the research and development of these devices, as well as FDA review considerations to potentially streamline the process to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.

You may submit comments to the docket about this action until June 6, 2016. The docket will open on Monday, March 7, 2016.

The draft guidance can be found by searching for docket number FDA-2016-D-0539 on www.regulations.gov.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health