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Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff

Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff

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FDA 官方历史目录记录;Final guidance;发布日期:2021-05-20。官方主题:Premarket, Investigational Device Exemption (IDE), Neurological。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov