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 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Neurology and Medical Devices
The neurological device space is fast growing, particularly in the areas of device interfaces as well as intervention and surgical neurological devices. Despite this rapid technological progress, it is still difficult to collect samples from the nervous system and often systemic markers are not available. Clinically neurological devices face significant issues with testing for safety and effectiveness. Developing regulatory tools, methods, and models that help to understand clinical manifestation of neurological diseases and non-clinical methods to evaluate the safety of these devices present an opportunity to significantly reduce the regulatory burden of bringing these potentially life-saving devices to market.
Regulatory Science Gaps and Challenges
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 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.
Neurology Program Activities
The Neurology Program focuses on regulatory science research in these areas:
- Tools and test methods to support an electrophysiology regulatory framework, including human induced pluripotent stem cell-based in vitro models, electrophysiological computational models, and high-throughput electrophysiology laboratory platforms to reduce these gaps between scientific innovation and medical device review.
- Quantitative biomarkers for neurological disorders and injuries that can be used to determine the effectiveness of neurological devices in areas where current techniques do not exist or depend on highly variable qualitative methods.
- Methods and models to better understand and quantify the long-term safety, biocompatibility, and performance of neural implants in the brain, spinal cord, and spinal nerves.
For more information, email OSEL_neurology@fda.hhs.gov