Elon Musk's Neuralink before allowing the brain implant company to test its device in humans.
Reuters reported last month that FDA inspectors found problems with record keeping and quality controls for animal experiments at Neuralink last June, less than a month after the startup said it was cleared to test its brain implants in humans.
Neuralink, which first tested its device in monkeys and other animals, is now testing the device in humans. The company makes a brain-chip which enables paralyzed patients to control a computer using only their thoughts.
In a letter to the FDA on Monday, Democratic U.S. Representative Earl Blumenauer said he was concerned the agency ignored «troubling evidence» of animal testing violations that had been raised dating back to at least 2019.
Blumenauer also cited reports by Reuters since late 2022 that described employees' complaints of «hack jobs» of animal experiments due to a rushed schedule, causing needless suffering and deaths. Employees also worried that data quality would be compromised, the media organization reported at the time. He asked the FDA to explain how it reconciled reports of such lapses with its decision to authorize Neuralink's human trial.
«These alleged failures to follow standard operating