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Investigational Device Exemption Program

The Investigational Device Exemption (IDE) program allows for the investigation of medical devices, including implanted brain-computer interfaces.

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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 ...