Regulation of Biofeedback Devices: 

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Clinical biofeedback devices are regulated by the US Government’s Food and Drug Administration (FDA) and in SA such devices need to approved by the SA Department of Health (EC Declaration of Conformity by the manufacturer in terms of EC Directive 93/42/EEC or 90/385/EEC).

 

You should not use any biofeedback device for clinical applications that is not labelled as safe and effective by the FDA unless you are using it for approved research. Look at research papers in the field to identify the superior quality manufacturers of equipment that have effective sampling of signals capacity to meet the stringent research markers.

 

Each device approved by the FDA has a “label” stating those uses that the FDA is of the opinion   have been sufficiently well demonstrated to be efficacious.

You must inform your clients in writing if you use the device off label, in other words for a purpose other than uses listed by the FDA.

For a more complete discussion of FDA considerations including who can prescribe the use of biofeedback devices, please see the discussion at  “Food and Drug Administration (FDA) Biofeedback Equipment Labeling and Approval Issues” – aapb.org

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How to Distinguish between Legitimate Biofeedback/Neurofeedback Devices (January 2009 Report – BCIA)

The market of therapeutic biofeedback devices has become flooded with a number of machines purporting to be biofeedback machines when, in fact, they either operate on different principles or otherwise provide an unconventional form of “feedback” to the individual.

This document is meant to offer distinctions from a laboratory research perspective.

Traditionally, biofeedback machines make use of any of a number of sensors that can quantify specific physiological parameters in the body, such as heart rate, blood pressure, skin temperature, muscle tension, sweat gland activity…, etc. Neurofeedback is similar in that it employs electrodes attached with a conducting gel to certain areas of the scalp to monitor EEG (brainwave) patterns. These quantifiable parameters are all indicative of the unconscious state of the autonomic nervous system (for biofeedback) or of brain function (for neurofeedback). The devices typically utilize blinking lights, audible tones or computer software images that alert the individual to their state of being, bringing it into their conscious mind, and providing them with a means to gain control over these otherwise unconscious bodily or cognitive functions. Sensors for biofeedback include: galvanic skin response (skin voltage is very sensitive to moisture levels from sweat glands), thermistors (to measure skin temperature), photoplethysmography (or PPG’s for measuring peripheral blood flow and heart rate), electromyographs (for measuring muscle tension) and others. Wikipedia and other online sources provide ample examples.

Biofeedback has enjoyed great success in training numerous conditions including those related to muscle tension (temporomandibular-joint disorder, back pain, tension headaches/migraines, tendonitis, incontinence), plus anxiety, hypertension, epilepsy, some chronic pain conditions, certain breathing disorders, some types of cardiac arrhythmias, and substance abuse.

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Neurofeedback can also address a number of these but is more commonly used to address learning and psychological disorders such as ADHD, obsessive-compulsive disorder, and depression, to name just a few.

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