FDA Scrutiny on Neuralink: Quality-Control Issues Identified

Elon Musk’s Neuralink encountered regulatory scrutiny from the US Food and Drug Administration (FDA) following the billionaire’s announcement that the startup had received approval from the regulator to commence human trials of its brain chips. According to a recent report by Reuters, FDA records revealed quality-control issues at Neuralink’s animal laboratory in California.

Identified Quality-Control Issues

The FDA inspection, conducted shortly after Neuralink’s assertion of FDA clearance for human trials, unearthed deficiencies in record-keeping and quality controls pertaining to animal experiments at the California facility. Specific issues included a lack of documentation regarding the calibration of certain tools and gaps in records concerning individuals responsible for ensuring quality control.

Timeline of Discovery

The discrepancies were detected during an FDA inspection spanning from June 12 to June 22, 2023, as reported by Reuters. Notably, Neuralink had announced in May 2023 that it had received FDA approval to initiate human trials. However, the FDA records suggest ongoing concerns regarding the regulatory compliance of the facility.

Discrepancies and Regulatory Response

While the FDA flagged concerns at the California site dedicated to animal research, no immediate regulatory action was taken. Reuters noted that the FDA did not deem the identified issues significant enough to warrant immediate intervention. An FDA spokesperson indicated that Neuralink had provided adequate information to support its approval for human testing, with the agency committing to monitor participant safety through regular reports.

Neuralink’s Response

Neither Neuralink nor Elon Musk responded to requests for comment from Reuters or Business Insider regarding the FDA’s findings. The startup, founded in 2016 by Musk, aims to implant chips in human skulls to facilitate computer interaction via brain signals, with a focus on assisting individuals with paralysis.

Past Regulatory Scrutiny

Neuralink has previously encountered regulatory scrutiny, including reports of animal mistreatment during device testing in 2022. However, the FDA found only one violation, which Neuralink had already reported. Musk’s other ventures, such as SpaceX and The Boring Company, have also faced regulatory attention, reflecting the intense pace and scrutiny associated with Musk’s ambitious projects.