FDA slams California company for selling brain devices without approval

Regulatory NewsRegulatory News | 17 March 2022 |  By 

The US Food and Drug Administration (FDA) has come down hard on a California-based company that it says was selling neurostimulation and electroencephalogram (EEG) signal processing devices without the agency’s approval. In a warning letter, regulators also called out the company for failing to follow through on a corrective action plan.
On 15 March, the FDA published a warning letter dated 28 February to NeuroField Inc. based in Bishop, CA, that called out the company for selling products without the necessary authorization or approval. The agency said that based on its inspection of the company’s facilities in September and October last year, NeuroField was marketing its NeuroField X3000/X3000 Plus, NeuroField Q21, NeuroField64, and NeuroField EEG without receiving a premarket approval (PMA), 510(k) clearance or an investigational device exemption (IDE).
The company claims its NeuroField X3000 and NeuroField Q21 are biofeedback devices that do not require premarket notification as they are considered battery-powered prescription use devices indicated for relaxation training and muscle reeducation. The FDA, however, says the company’s marketing of the products goes beyond that definition and thus its products are subject to greater regulatory oversight.
“Based on our review of materials collected during the inspection and other available information, including statements on your firm’s website … these devices are intended for uses that exceed or otherwise differ from the classification … such that premarket notification is required prior to introduction or delivery for introduction of these devices into interstate commerce for commercial distribution,” the agency said.
The agency also includes instances in its letter as evidence where the company makes medical claims on its web site about its products that would require regulatory oversight. Regulators have asked NeuroField to cease any commercial distribution or misbranding of its products that violate statutory requirements to get FDA marketing approval.
As of publishing this article, the company’s web site appears to have been taken offline with a message that reads it is under maintenance.

Besides the argument by the FDA the company was marketing products illegally, the agency also levied other accusations, such as it failed to adequately address complaints about its products, establish a corrective and preventive action (CAPA) plan, and conduct quality audits.
The warning letter was addressed to NeuroField co-founder and CEO Nicholas Dogris, who told Regulatory Focus they plan to respond to the FDA very soon and clear up any issues.
“We are currently finishing our formal response to the warning letter that you are referencing and it should be sent to them on March 21, 2022,” he said. “We are working closely with the FDA to correct any issues for purpose of remaining in compliance in a timely fashion.”

Warning letter


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