IEEE pulse
-
Review
FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators.
The U. S. Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of medical devices. ⋯ Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4].