Medical devices intended to slow, stop, or reverse the effects of neurological disease (neurological devices) face challenges with regard to collecting safety and efficacy data in a clinical study, when less invasive pharmacotherapy approaches may be better understood or more-well accepted in the clinical community. The Center for Devices and Radiological Health (CDRH) is issuing this guidance for Industry and FDA staff to assist in considering the benefits and risks of medical devices that target either the cause or progression of the neurological disorder or condition such as Alzheimer’s disease, Parkinson’s Disease, or Primary Dystonia, rather than their symptoms, and importantly, address an unmet medical need of the patient.
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. This guidance provides considerations for the research and development of such devices, as well as FDA review considerations to aid in the promotion of this innovative sector of technology.
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 current 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. For additional information, please see the guidance document, Request for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocumen ts/ucm311176.pdf)