“- in determining the safety and efficacy of Neurofeedback, we strongly recommend focusing more on the credentials and qualifications of the practitioners.” - Dr. Blake Ausmus

Introduction

One of the most common questions we get surrounding Neurofeedback Therapy is whether it's "FDA or Health Canada approved." However, the answer to this question is not as straightforward. In this blog post, we aim to shed light on this query, clarify the role of the FDA and Health Canada, and explore what people genuinely want to know when they ask if these regulatory bodies approve Neurofeedback.

Understanding the FDA and Health Canada

The FDA, or the US Food and Drug Administration, is a vital government agency tasked with safeguarding public health by ensuring the safety and efficacy of various products, including drugs, medical devices, and foods. Similarly, Health Canada plays a crucial role in regulating and approving medical devices in Canada. However, there is an essential distinction to make here:

Neurofeedback is a Treatment Modality

Neurofeedback Therapy is not just a device; it is a treatment modality. Interestingly, treatment modalities like psychotherapy are not subject to FDA or Health Canada regulations. This means that Neurofeedback Therapy, as a form of psychotherapy, does not require "FDA and Health Canada approval." It operates in a category outside the purview of these regulatory bodies.

Device Recognition by the FDA and Health Canada

While Neurofeedback Therapy itself doesn't require FDA or Health Canada approval, the devices used in the process can be subject to recognition or clearance by these regulatory bodies. These devices are categorized based on risk and safety levels, ensuring they meet specific standards. This recognition is primarily a way to manage manufacturers' claims in selling their devices. This is why you will often see Neurofeedback Therapy devices being marketed as "a general wellness tool," as that is a claim that requires less proof and red tape.

If we are really nit-picking, we can find a lot of devices involved in Neurofeedback Therapy that realistically will never be recognized by organizations as medical devices. For example, we use a comfortable chair, earphones, a computer, and a television as part of the treatment. This can further complicate the question of whether Neurofeedback is FDA or Health Canada" approved."

Obtaining recognition from the FDA can be a complex and costly process, which poses challenges for many businesses. Also, just because the FDA or Health Canada may clear a device, it does not necessarily mean that it is effective or safe for any use. Much like if a microwave oven is registered with the FDA, it's not safe to put a fork inside it. As such, it is understandable that many manufacturers prefer not to make any claims about their devices and, instead, sell them "as is" with a short disclaimer that it is not intended for medical or diagnostic purposes. In some ways, it is saying, "Here are some wires and microchips placed together; what you do with it is your business and not ours."

Off-Label Use of EEG Devices

It's worth noting that EEG (Electroencephalogram) devices can be used for Neurofeedback therapy in an off-label manner. Off-label refers to when a device is used for reasons other than what it is recognized for. Much like using a hammer to break glass or using a butter knife to open a sealed envelope - it is not what it was intended or approved for, but we find devices can still be effective and safe for different purposes. 

EEG devices can be designed for reasons other than use for treatment, such as simply detecting brain function. Professionals can repurpose these devices for Neurofeedback to provide real-time feedback on brain activity. Since this is still very safe and effective, it is a common practice.

The Real Question: Safety and Effectiveness

When people ask whether Neurofeedback is FDA and Health Canada-approved, they likely want to know whether it is safe and effective. To that, the answer is YES. We have found Neurofeedback to be incredibly safe and very effective.

However, in determining the safety and efficacy of Neurofeedback, we strongly recommend focusing more on the credentials and qualifications of the practitioners. A device may or may not have FDA or Health Canada recognition, but what the professional does with it will ultimately determine its safety and effectiveness when it comes to Neurofeedback Therapy. So, rather than asking, "Is this Health Canada approved?" you might consider asking instead, "What are the qualifications or expertise of the Neurofeedback Therapy provider?"

Conclusion

In conclusion, the question of whether Neurofeedback is FDA and Health Canada-approved is somewhat misleading. While the therapy itself doesn't require approval due to its classification as a treatment modality, there are devices that are used for Neurofeedback. Some of these devices have recognition or clearance from regulatory bodies like the FDA and Health Canada based on their safety and risk levels. At the same time, others are used safely and effectively off-label. Suppose you are concerned about the safety and effectiveness of Neurofeedback Therapy. In that case, we recommend asking about the qualifications of the practitioner and, if desired, asking for some of the research in your particular area of interest to determine if this modality might benefit you. 

If you'd like to know more about Neuorfeedback or the qualifications of our providors, please don't hesitate to click HERE to connect or call us at 587-333-6349. 💙

Disclaimer

Our content is for informational and educational purposes and is not a replacement for professional advice, diagnosis, or treatment. If you're facing mental health concerns, please seek help from a qualified professional for personalized guidance is vital. Every individual's situation is unique, so use the information here at your discretion. While we strive for accuracy, the field of psychology is ever-evolving, and our content may not always reflect the latest research. Please prioritize your privacy by avoiding sharing personal information in comments or interactions. Your well-being is our top concern, so use our content for educational purposes, but remember to rely on professionals for your specific needs.