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FDA Regulation of Implanted Brain-Computer Interfaces

The FDA regulates implanted brain-computer interfaces as medical devices, applying established device pathways and guidance. The agency has cleared and authorized investigational studies for invasive BCI technologies and continues to develop regulatory science and post-market oversight.

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Jan 31, 2026
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What are the FDA’s standards and recent oversight actions regarding invasive brain‑computer interface devices?

The regulates implanted brain‑computer interfaces (iBCIs) as medical devices and applies established device pathways and device‑specific guidance to them, including a 2021 final guidance on implanted ...