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FDA Finds NeuroField Failed to Report Device Failures
Devices Inspections and Audits
A February inspection of NeuroField’s facility in Bishop, California found the firm failed to report device failures for its neurofeedback devices, and it didn’t properly control products according to specifications, the FDA said.
The agency inspector identified 23 instances where customers reported functional or structural failures, but the events were processed as routine service repairs and not evaluated for MDR reportability.
The inspector also observed four instances where incoming in-process materials failed to meet specifications, but they were not documented, evaluated or segregated as nonconforming materials, according to the Form 483 report.