JAKARTA - A US lawmaker involved in health policy has asked the Food and Drug Administration (FDA) why they did not conduct an inspection of Elon Musk's Neuralink before allowing the brain implant company to test its tools on humans.

Reuters reported last month that FDA inspectors found problems with recording and quality control for animal trials in Neuralink in June, less than a month after the startup said it had obtained permission to test its human brain implants.

Neuralink, which first tested its tools on monkeys and other animals, is now testing the tool on humans. The company manufactures a brain chip that allows paralyzed patients to control computers with only their minds.

In a letter to the FDA on Monday, March 25, US MP from the Democratic Party, Earl Blumenauer, said he was concerned the agency ignored the worrying evidence about animal testing violations that had been filed since at least 2019.

Blumenauer has also cited a report by Reuters since late 2022 describing employee complaints about barreled work'' from animal trials due to a hasty schedule, causing unnecessary suffering and death.

Employees are also worried that the quality of the data will be disrupted. He asked the FDA to explain how they reconcile the report on the breach with their decision to allow the Neuralink human trials.

"This alleged failure to follow standard operating procedures has the potential to endanger animal welfare and disrupt data collection for human trials," wrote Blumenauer, who serves on the House Ways and Mean subcommittee on health.

Meanwhile the FDA said it would respond directly to the MPs. The agency also said it routinely conducts inspections after human trials were approved. When inspecting Neuralink, the FDA said it did not find any violations that would undermine the safety of the trial.

Neuralink did not immediately respond to questions. In recent years, a number of device companies have started testing brain implants like this in humans, including Synchron and Blackrock Neurotech, both of which have demonstrated the patient's ability to control certain actions with their minds.

Last week, Neuralink presented a live broadcast on Musk's social media platform X, showing how the first patient to be implanted with his brain apparatus was able to play online chess using his mind. Noland Arbaugh, a 29-year-old man who was paralyzed under his shoulder after a diving accident, also posted a comment on X conveying his mind.


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