IEEE pulse
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When it comes to health and fitness, there's an app for just about everything. Want to track how many steps you've taken today? There's an app for that. Want to track the calories you've consumed? There's an app for that, too. And, if you want to know if you got a good night's sleep last night, well, now there's also an app for that.
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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].
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Neural implantation of devices and the subsequent tissue response are complex and cascading physical and biological phenomena. Creation of reliable neural interfaces remains a significant challenge. Penetrating central nervous system interfaces persist as the most challenging to realize but continue to be the most attractive because of the information bandwidth advantages they provide. ⋯ The ultimate realization of reliable penetrating neural interfaces will require careful science and engineering approaches incorporating knowledge of relevant and critical biological, physical, and chemical factors, especially their interrelationship. In this article, we describe a comprehensive strategy to assess the reliability of penetrating central neural interfaces based on the biology and pathology of the injury and indwelling tissue responses. Our strategy involves a parallel, self-informing approach by simultaneous development of new in vitro and in vivo assessment techniques as well as using these state-of-the-art techniques to conduct accelerated lifetime assessments of neural interface degradation.