When will the US FDA grant Neuralink permission to sell and implant a brain-machine interface device into general consumers?

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Neuralink Corporation is an American neurotechnology company founded in 2016 by serial entrepreneur Elon Musk and others, developing implantable brain–machine interfaces (BMIs).

Since its founding, the company has hired several high-profile neuroscientists from various universities. By July 2019, it had received $158 million in funding (of which $100 million from Musk) and was employing a staff of 90 employees.

At that time, Neuralink announced that it was working on a “sewing machine-like” robot capable of implanting very thin "threads" into the brain, demonstrated a system that read information from a lab rat's brain via thousands of electrodes (many times more than the current maximum for systems used in human brains), and Musk announced an aspirational goal to start experiments with humans in 2020, pending FDA approval.

In the short term, the company aims to develop brain-machine interfaces to assist individuals with serious physical or neurological conditions; but the longer term goal of the company is to enable human-AI symbiosis and grant superhuman cognition to anyone who wants it, as well as a form of digital immortality.

This question asks: When will the US Food and Drug Administration grant regulatory approval allowing any device developed in whole or in part by Neuralink Corporation to be sold, and implanted into the brains of human consumers?

You can find information on the FDA's Regulatory Overview for Neurological Devices here.

The implantation surgery need not actually occur by that date (or at all) in order for this question to resolve positively; this question focuses solely on when regulatory approval will be obtained.

This question resolves >2050 if no approval is given before 2050. The question resolves ambiguously if the FDA is abolished, or if its role is changed such that regulatory approval is no longer required for this procedure.


2020-08-17 : removed § triggering positive resolution upon Investigational Device Exemption or Humanitarian Device Exemption. See this thread.

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