SOURCE RECORD / S0037
Implanted BCI devices for paralysis or amputation: FDA final guidance availability
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
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