FDA Requirements for Equipment

Occasionally, concerns arise after one company or another publishes a press release indicating that their device has FDA certification or clearance. Let’s be clear that this is a marketing technique and not a requirement.

Anyone—lay person or professional—can get results with any well-manufactured neurofeedback equipment, and this has nothing whatsoever to do with the FDA.

The FDA does not require any neurofeedback equipment to be listed or certified. It does not require that trainers be “certified” by anyone either. There is an option for manufacturers who wish to apply voluntarily for a 510k. This means they spent the money to hire an attorney, fill out a bunch of paperwork, paid fees to the FDA and got a document stating that their equipment appears to be the same as other equipment that has been inspected.

In addition, there is no certification required in Canada, in any European countries of which I’m aware, or in Australia. I don’t know about Asia, but certainly any place that chooses to require certifying a device is not basing their decision on FDA guidelines.

Obviously if you are charging $3,000-5,000 for an amplifier (when the Q-WIZ and Optima 4 are about $1,100 to do the same work with the same quality), you can afford to pay to be certified, and then yu can convince people who don’t really understand the FDA’s regulations that they need to purchase FDA “certified” units. All the equipment we sell (including electrodes and HEG headbands and software, etc.) does not require FDA certification or clearance. Neither do any devices from companies that have paid to get it.

Terms like “medical grade” equipment sound pretty impressive. The verbiage is really a nice marketing technique to make it sound different from other options. When they say “medical grade,” they simply mean that they have gone through the steps and spent the money to have their equipment registered (not tested or certified) by the FDA.in a process known as 510(k). According to the FDA’s own website (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3019 ), biofeedback devices are exempt from 510(k) requirements. Certainly, any company that wishes can apply to have their device certified.

Another advantage to getting the FDA to register your device–and then calling it “medical grade”–is that it makes things tougher for foreign competitors. There are excellent alternatives from Argentina, Australia and the Netherlands which have a harder time “proving” what the FDA calls “good manufacturing practices,” even though their manufacturing practices are as good or better than those in US companies, simply because they are overseas. In terms of specs, in terms of safety requirements, in terms of the quality of the equipment itself–and in terms of the number of NF providers who prefer those devices–they are in every way equal or better.

The FDA recognizes “biofeedback” (no specific category for neurofeedback) for five purposes:

1. General relaxation

2. Relaxation for Stress Management

3. Muscle relaxation

4. Muscle relaxation for pain management, and

5. Quality of life management.

It exempts biofeedback devices because it doesn’t consider them very dangerous or invasive. Apparently there have not been many (or any) complaints about misuse or damage to clients–which is also the case with the much more invasive light/sound devices. To the best of my knowledge the FDA doesn’t say who can buy them or who can use them.