As part of the FDA’s ongoing effort to ensure patients and providers have timely and continued access to safe, effective, and high-quality medical devices, the FDA launched a website on November 10 to help sponsors and innovators bring neurological medical devices to the U.S. marketplace.
The website provides:
- 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.
This website is part of the FDA’s continuing support of the White House BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative focused on understanding the human brain and uncovering new ways to treat, cure, and event prevent brain disorders.
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or[email protected].