FDA Neurology Drug Program

FDA NEUROLOGY DRUG PROGRAM

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The Neurology Program in the FDA's Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patient access to innovative neurology devices that are safe and effective. This is one of the 20 research programs in CDRH's Office of Science and Engineering Laboratories (OSEL).
 

The major regulatory science gaps and challenges that drive the Neurology Program are:

• Lack of standardized tools to predict clinical translation of novel medical devices in development, including the lack of human physiology-based in vitro test methods to assess the effectiveness of neurological electrophysiological devices and biosafety of emerging device materials.

• Lack of a robust regulatory strategy, including biomarkers for demonstrating performance and evaluating efficacy of novel devices for early detection and medical intervention in the management of neurological disorders and injuries.

• Significant regulatory gaps in the critical evaluation of both recording and stimulating neural interface devices for central and peripheral neural tissue that hinders long-term adoption due uncertainty in safe stimulation levels, implant stability, biocompatibility, and device effectiveness.

The Neurology Drug Program is intended to fill these knowledge gaps by fostering predictable neurology device assessment, development, and innovation and by making the FDA better prepared for addressing microfluidic devices flow-related issues at both the premarket and postmarket stages in the medical device lifecycle.