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FDA Issues Guidance on Implanted Brain-Computer Interface Devices

June 1, 2021

The FDA offers advice in a new guidance for developers of implanted brain-computer interface (BCI) devices who are seeking investigational device exemptions or pre-submission feedback from the agency.

Sponsors need to ensure that the failure of any single component of the implanted BCI device doesn’t cause an unacceptable risk during use, the agency advised.

Developers also need to consider electrical safety and electromagnetic compatibility, because the implanted devices may expose the operator and patient to electrical energy hazards, the FDA said.

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