FDA Launches Website to Help Sponsors and Innovators Develop Neurological Medical Devices

As one of the partners in the White House “Brain Research through Advancing Innovative Neurotechnologies Initiative” (BRAIN), FDA is “working to enhance the transparency and predictability of the regulatory process for developers and innovators of neurological medical devices.” Recently, FDA announced a new website “intended to assist neurological device developers, sponsors and innovators with navigating the regulatory process. It provides insight into the premarket review process and the scientific and ethical considerations to bringing new neurological devices to market.” Click here to visit the new FDA site, and NIH
or the White House to learn more about the BRAIN initiative. If you need help with QSR system development, compliance or a pre-sub meeting with CDRH, feel free to contact us.