FDA Regulation of Invasive Neural Recording Electrodes: A Daunting Task for Medical Innovators

Welle C.G.

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FDA Regulation of Invasive Neural Recording Electrodes: A Daunting Task for Medical Innovators

机译：FDA的有创神经记录电极法规：医疗创新者的艰巨任务

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In this paper, the basics of FDA regulatory premarket process were introduced that relates to chronically implanted recording devices in the central or peripheral nervous system.

机译：在本文中，介绍了FDA监管上市前过程的基础，这些过程与在中枢或周围神经系统中长期植入的记录设备有关。

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《Pulse, IEEE》 |2012年第2期|p.37-41|共5页
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Welle C.G.;
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FDA Regulation of Invasive Neural Recording Electrodes: A Daunting Task for Medical Innovators

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