Is Neurofeedback FDA Approved?
Customers often ask this question; is neurofeedback FDA approved? Neurofeedback is a technique known as EEG-operant conditioning. The Food and Drug Administration (FDA) approval for this category of devices is classified into Classes I, II, III. Myneurva uses Class II medical devices that are approved by the FDA.
According to the website, the FDA is responsible for protecting the public by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA is responsible for advancing public health by speeding innovations that make medical products more effective, safer, and more affordable.
There are three levels of classification by the FDA for such devices. Class I devices have the lowest regulation level because they present a minimal level of risk for harm.
Devices in Class II are those for which special controls are deemed necessary by the FDA. These controls are essential to assuring the effectiveness of devices. Plus, this level of oversight ensures that compliance methods are in place. Myneurva uses FDA approved Class II.
Class III devices require the strictest regulation because they generally support or sustain human life. As stated, Myneurva uses approved Class II amplifiers to acquire EEG and perform neurofeedback.
Now that we have answered the question; Is Neurofeedback FDA Approved, below please find some more articles on Neurofeedback.