There is an ongoing effort within the field of neurofeedback to clarify the FDA requirements for EEG biofeedback equipment and software. We include the information that is currently believed to be correct and will continue to update this section with any clarifications we receive.

Overview of the issue

Neurofeedback equipment registered with the FDA is considered a medical device. There are companies tha follow these guidelines. A medical device is supposed to be sold only sold to licensed providers. There are a few companies selling neurofeedback instruments who will sell to anyone, not just licensed providers. Some of them have not registered their devices as medical devices with the FDA. That’s because the FDA guidelines, until recently, have seemed to be somewhat ambiguous regarding neurofeedback equipment, nor has the FDA paid much attention to it.

A few companies who are registered with the FDA sell equipment to dealers. Some of those dealers sell the equipment directly to consumers with no licensed provider involved. It’s unclear if this is allowed under FDA guidelines. Many in the industry think it’s not allowed, but this too must be sorted out.

More detail on what are the FDA guidelines and what they mean

There are a number of equipment and software vendors for neurofeedback. Several of the top-tier companies are registered with the FDA and have gotten 510k certification from the FDA. Those documents are for the “intent to market a device.” This means they meet certain standards of manufacturing and quality-control based on strict FDA guidelines. The FDA does not assess the equipment, the software, or its quality as part of its 510k approval. It just ensures the company meets the process guidelines for manufacturing and quality.

There are other manufacturers of equipment and software who are not registered at all with the FDA. Information obtained recently from an FDA source suggests that all manufacturers of neurofeedback equipment and software should have submitted documents registering with the FDA. If that’s true, they are in violation of FDA guidelines. These companies could be subject to FDA scrutiny. There has been some uncertainty regarding FDA guidelines in the past. Some companies chose to interpret the guidelines in the way most conducive way to their goals without direct contact with the FDA.

What is biofeedback allowed to do under FDA regulations?

The FDA has “grandfathered” all biofeedback equipment as a device to promote relaxation. No other claims can be made. In 1976 when the FDA Medical Device Act was approved, relaxation was all they included under biofeedback at the time. Any company that submits and gets approval for FDA’s 510K is stating their equipment meets “substantial equivalence” to all previous equipment built in 1976 or before. That is, it can promote relaxation. Once approved for that, no company has to go through the expensive process of being approved by the FDA to help with a condition such as ADHD or anxiety.

The equipment is being used widely to deal with all kinds of conditions. No manufacturer states any conditions that their equipment treats. They stay away from any such claims as any such claims would be instantly looked at harshly by the FDA.

Off-Label Use

Clinicians are a different story than manufacturers. They can use devices and medications “off-label” for patients as they see fit. No clinician should make any claims that neurofeedback cures ADHD or anxiety either. If they did, they’d have a problem with their licensing board. But they can use a variety of tools, including neurofeedback, to help in the process. Since neurofeedback primarily helps both relaxation and improvements in self-regulation, there is really little need to make claims for the technology. Clinicans are not subject to FDA regulation for use in these ways.

Will the FDA approve neurofeedback for treatment of ADHD, anxiety, and other conditions?

The cost to obtain approval for a device to treat ADHD or anxiety from the FDA is huge – millions and millions of dollars. No company will fund these efforts. Why? Any company who funds approval for neurofeedback to treat ADHD would also instantly get approval for all devices that currently exist since they are all considered “substantially equivalent” by the FDA.  The company would open the market for their competitors. No one will put up funding under those conditions.

If not for that, many conditions would be able to get approval by the FDA. Certainly ADD/ADHD, anxiety, and depression would quickly gain acceptance after clinical trials. Many other conditions would also.  Funding of the expensive clinical trials that are required by the FDA require huge investments no one is willing to make.

Who can equipment and software be sold to?

As a medical device, manufacturers of neurofeedback equipment with 510K FDA registration can sell only to licensed health providers. There may be exceptions in the few places that don’t license mental health providers. Even then, appropriate credentials are required.

No manufacturer can sell equipment to a consumer. A licensed health clinician can provide equipment to a client or patient. However, the responsibility for individual use would then fall under their licensure.

The problem with manufacturers of equipment that have not registered with the FDA is that they can sell directly to non-licensed providers without any recourse. As mentioned earlier, it appears that these manufacturers may be in violation of FDA guidelines, and that they too should not be selling directly to unlicensed parties directly, particularly consumers. However, the FDA guidelines were unclear until recently, and those guidelines are being more clarified.

There are manufacturers with 510K approval who have been selling directly to consumers and non-licensed individuals, or have been selling equipment to distributors who resell to anyone. This is also being looked at closely within the neurofeedback industry. The main professional organizations in the field, ISNR, AAPB, and BCIA are all concerned about consumers purchasing neurofeedback equipment without appropriate supervision or training.