FDA has launched a new website aimed at helping bring neurological medical devices to the U.S. market. The website is part of the agency’s support of the White House BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative.
“This webpage is 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.” – FDA
The agency provides the following on the site:
- An overview of the FDA regulatory process, and how it applies to developers and sponsors of neurological devices
- Standards and guidances for neurological devices
- Regulatory science information related to neurological devices
- Information on patient perspectives and real world data in the development of neurological devices
- Resources, webinars, and events of interest to sponsors and developers of neurological devices