<div dir="ltr"><div class="gmail_default" style="font-size:small">You do not need FDA approval to use an EEG device for recording and research purposes, unless specifically required by your IRB or research institution. Any device which has US safety certifications and FCC Part 15 certification can be used safely on human subjects. <br><br>CE is a broader category - a manufacturer can affix the CE mark after certifying (or having certified by a registered body) that the product comply with all necessary EU regulations for the intended class of use. That means if a product is specified as a medical product then it must comply with medical certifications ad must be manufactured in a compliant facility with medical grade vigilance (EN601.1 and EN13485). Consumer and research devices do not require this level of certification, but safety and radio emission requirements must also be met (also recycling, hazardous substances excluded in manufacture and so on).<br></div><div class="gmail_default" style="font-size:small">FDA and other medical certifications are required if a device is marketed for use in diagnostic or therapeutic applications, typically administered by trained medical professionals. Some institutions insist on this level of certification for devices even if they are not used in this context, but are applied to human subjects.<br></div></div><div class="gmail_extra"><br clear="all"><div><div class="gmail_signature"><div dir="ltr"><div><div><div><div><div>Geoffrey Mackellar PhD<br></div>CEO, Emotiv Research Pty Ltd<br></div>Co-founder and CTO, Emotiv, Inc.<br></div><a href="mailto:geoff@emotiv.co" target="_blank">geoff@emotiv.co</a><br></div><a href="http://www.emotiv.com" target="_blank">www.emotiv.com</a><br></div><a href="http://www.emotiv.co" target="_blank">www.emotiv.co</a><br></div></div></div>
<br><div class="gmail_quote">On Fri, Mar 27, 2015 at 4:31 AM, Makoto Miyakoshi <span dir="ltr"><<a href="mailto:mmiyakoshi@ucsd.edu" target="_blank">mmiyakoshi@ucsd.edu</a>></span> wrote:<br><blockquote class="gmail_quote" style="margin:0 0 0 .8ex;border-left:1px #ccc solid;padding-left:1ex"><div dir="ltr">Dear Doron,<div><br></div><div>Interesting topic. I heard a rumor that the FDA-approved EEG recorder in US (I don't know which) supports only the classical 10-20 system channels... I could be wrong though. Anyone on the list please tell us what you know about this. I'm curious to know too. Thank you.</div><div><br></div><div>Makoto</div></div><div class="gmail_extra"><br><div class="gmail_quote">On Mon, Mar 23, 2015 at 2:10 PM, Friedman Doron <span dir="ltr"><<a href="mailto:doronf@idc.ac.il" target="_blank">doronf@idc.ac.il</a>></span> wrote:<br><blockquote class="gmail_quote" style="margin:0 0 0 .8ex;border-left:1px #ccc solid;padding-left:1ex">
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<p class="MsoNormal" style="text-align:left;direction:ltr">Hi,<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr"><u></u> <u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">This is not directly related to EEGLAB but perhaps of interest to many of us: my understanding is that none of the devices with active electrodes have any standard approval, such
as CE (Europe) or FDA (US). Does that mean all of us who are using them in research labs are not covered legally? And what about commercial applications, such as neurofeedback?
<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr"><u></u> <u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">Thx<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr"><u></u> <u></u></p>
<p style="margin-right:0cm;margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;text-align:left;direction:ltr">
<u></u><span>-<span style="font:7.0pt "Times New Roman"">
</span></span><u></u><span dir="LTR"></span>d<u></u><u></u></p>
<p class="MsoNormal" dir="RTL"><span dir="LTR"><u></u> <u></u></span></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">Dr. Doron Friedman<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">Senior Lecturer<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">Sammy Ofer School of Communications<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">Office phone number: <a href="tel:%2B972-9-9527654" value="+97299527654" target="_blank">+972-9-9527654</a><u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">Room C225, Sammy Ofer building<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">The Interdisciplinary Center, Herzliya<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">PO Box 167, 46150<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr"><u></u> <u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr">Director, Advanced Reality Lab<u></u><u></u></p>
<p class="MsoNormal" style="text-align:left;direction:ltr"><a href="http://avl.idc.ac.il" target="_blank">http://avl.idc.ac.il</a><u></u><u></u></p>
<p class="MsoNormal" dir="RTL"><span dir="LTR"><u></u> <u></u></span></p>
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