Devices

Petition Urges FDA to Create Pathway for Brain-Computer Interfaces

A new citizen petition is urging FDA to establish a regulatory framework for implantable brain-computer interfaces (BCIs) designed to expand human sensory perception beyond the natural limits of human vision. The just-posted petition, filed by Ali Afshar of Age Reversal Unity in New York, asks FDA to develop guidance for evaluating implantable BCIs capable of translating portions of the electromagnetic spectrum that humans cannot naturally perceive into neural signals interpretable by the brain.

Among its six requests, the petition asks the agency to develop guidance for sensory augmentation devices, establish a regulatory framework for medical devices that detect non-visible electromagnetic signals, encourage research by Elon Musk’s Neuralink Corp. and other BCI developers, prioritize regulatory review of sensory augmentation technologies through existing expedited programs, collaborate with federal agencies and academic institutions on scientific standards, and promote development of technologies that could safely expand human sensory perception.

The petition argues that humans naturally perceive only a small portion of the electromagnetic spectrum through visible light and cannot directly detect radio waves, infrared radiation, ultraviolet light, X-rays or gamma rays without technological assistance. Afshar contends that advances in brain-computer interface technology could eventually enable implantable devices to convert information from additional portions of the electromagnetic spectrum into neural activity that the brain could interpret, potentially creating entirely new forms of sensory perception.

The filing repeatedly cites public statements by Musk regarding the limitations of human perception and the long-term potential of brain-computer interfaces. It argues that Musk's comments have generated public interest in technologies capable of extending human sensory capabilities and asserts that Neuralink is well positioned to pursue such research because of its technological and financial resources.

While acknowledging that current science has not demonstrated technology capable of allowing humans to perceive the entire electromagnetic spectrum, the petition argues that expanding human sensory perception represents an important long-term scientific objective deserving regulatory support and research investment.

This is not the first petition from the group. A 2025 petition, which was denied earlier this year (see story), sought a regulatory framework for conducting expedited clinical trials of aging-related therapeutics within a nine-month timeframe. In denying the petition, FDA said it “ does not believe that issuing such a one-size-fits-all framework is scientifically appropriate or in the best interests of public health.”

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