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FDA leapfrogs guidance on brain-computer interface devices - Mass Device

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A researcher instructs a patient on how to move an artificial hand using a brain/computer interface device.

The FDA today issued leapfrog guidance for nonclinical testing and study design related to implanted brain-computer interface (BCI) devices.

Leapfrog guidance allows the agency to share its initial thoughts on emerging technologies that are early in development but appear likely to be of importance to public health, according to a Federal Register notice. The guidance offered by the FDA today represents its initial thinking, as recommendations may change down the line.

Get the full story at our sister site, Medical Design & Outsourcing.

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