FDA WARNING_LETTER - NeuroField, Inc. - October 06, 2021

The FDA conducted an inspection of Neurofield, Inc. (Bishop, CA) from September 28 to October 6, 2021, identifying significant violations. The firm manufactures neurostimulation and EEG signal processing devices, including NeuroField X3000/X3000 Plus, NeuroField Q21, NeuroField64, and NeuroField EEG.

These devices are deemed adulterated under section 501(f)(1)(B) of the Act because Neurofield, Inc. lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. They are also misbranded under section 502(o) for failure to provide premarket notification (510(k)). While some devices were listed as biofeedback devices (21 CFR 882.5050) and exempt from 510(k) for specific uses, the inspection revealed they are marketed for uses beyond this classification, such as stimulation-based treatment and as electroencephalographs (EEGs), requiring premarket notification. The software products, NeuroField64 and NeuroField EEG, also appear to meet the device definition and lack proper clearance.

Furthermore, the devices are adulterated under section 501(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include: 1. **