SOURCE RECORD / S0037

Implanted BCI devices for paralysis or amputation: FDA final guidance availability

Evidence A

Implanted BCI devices for paralysis or amputation: FDA final guidance availability

Authors or organization
US FDA
Published date
2021
Source type
regulatory_guidance
Technology route
implantable BCI
Function or setting
medical device development
Rights status
manual_review

Legacy aliases

EXO-S375

Related topics

  • BCI 最优方案
  • 中国监管与标准
  • AI×BCI 与外骨骼

Evidence summary

Evidence: FDA nonclinical guidance availability. Key figures: Federal Register 2021-10622. Limitations: Guidance is not product approval or clinical efficacy evidence.

Key figures

Federal Register 2021-10622

Limitations

Guidance is not product approval or clinical efficacy evidence

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SOURCE RECORD

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