Occasionally, concerns arise after one company or another publishes a press release indicating that their device has FDA certification or clearance. Let\u2019s be clear that this is a marketing technique and not a requirement.<\/p>\n
Anyone\u2014lay person or professional\u2014can get results with any well-manufactured neurofeedback equipment, and this has nothing whatsoever to do with the FDA.<\/p>\n
The FDA does not require any neurofeedback equipment to be listed or certified. It does not require that trainers be \u201ccertified\u201d 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.<\/p>\n
In addition, there is no certification required in Canada, in any European countries of which I\u2019m aware, or in Australia. I don\u2019t know about Asia, but certainly any place that chooses to require certifying a device is not basing their decision on FDA guidelines.<\/p>\n
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\u2019t really understand the FDA\u2019s regulations that they need to purchase FDA \u201ccertified\u201d 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.<\/p>\n
Terms like \u201cmedical grade\u201d equipment sound pretty impressive. The verbiage is really a nice marketing technique to make it sound different from other options. When they say \u201cmedical grade,\u201d 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\u2019s 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.<\/p>\n
Another advantage to getting the FDA to register your device\u2013and then calling it \u201cmedical grade\u201d\u2013is that it makes things tougher for foreign competitors. There are excellent alternatives from Argentina, Australia and the Netherlands which have a harder time \u201cproving\u201d what the FDA calls \u201cgood manufacturing practices,\u201d 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\u2013and in terms of the number of NF providers who prefer those devices\u2013they are in every way equal or better.<\/p>\n
The FDA recognizes \u201cbiofeedback\u201d (no specific category for neurofeedback) for five purposes:<\/p>\n
1. General relaxation<\/p>\n
2. Relaxation for Stress Management<\/p>\n
3. Muscle relaxation<\/p>\n
4. Muscle relaxation for pain management, and<\/p>\n
5. Quality of life management.<\/p>\n
It exempts biofeedback devices because it doesn\u2019t consider them very dangerous or invasive. Apparently there have not been many (or any) complaints about misuse or damage to clients\u2013which is also the case with the much more invasive light\/sound devices. To the best of my knowledge the FDA doesn\u2019t say who can buy them or who can use them.<\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
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\u2019s be clear that this is a marketing technique and not a requirement. Anyone\u2014lay person or professional\u2014can get results with any well-manufactured neurofeedback equipment, and this has nothing whatsoever to […]<\/p>\n","protected":false},"author":112,"featured_media":0,"parent":0,"menu_order":6,"template":"","meta":{"_acf_changed":false},"topic":[771],"class_list":["post-39048","answer","type-answer","status-publish","hentry","answer_topic-getting-started"],"acf":[],"yoast_head":"\n