<div dir="ltr">Dear Geoff and Jeff,<div><br></div><div>Thank you for your expert knowledge and quick responses!</div><div><br></div><div>> Any device which has US safety certifications and FCC Part 15 certification can be used safely on human subjects. <br></div><div><span style="color:rgb(31,73,125);font-family:Calibri,sans-serif;font-size:14.6666669845581px">> Many EEG systems are sold in the USA with FDA clearance for clinical use</span><br></div><div class="gmail_extra"><br></div><div class="gmail_extra">This is very good to know. Maybe my knowledge was based on very old information.</div><div class="gmail_extra"><br></div><div class="gmail_extra">Makoto</div><div class="gmail_extra"><br><div class="gmail_quote">On Thu, Mar 26, 2015 at 11:09 AM, Eriksen, Jeffrey :LGS Neurodiagnostics <span dir="ltr"><<a href="mailto:JEriksen@lhs.org" target="_blank">JEriksen@lhs.org</a>></span> wrote:<br><blockquote class="gmail_quote" style="margin:0px 0px 0px 0.8ex;border-left-width:1px;border-left-color:rgb(204,204,204);border-left-style:solid;padding-left:1ex">
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<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)">Any and all:<u></u><u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)"><u></u> <u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)">FDA clears devices for general safety and efficacy for clinical use in the USA but does not care about research use. UL/CSA/ETC etc. certifies electrical safety
specifically. You are covered legally for research use by your institutions IRB process, which should address the electrical safety issue and not care about FDA or clinical use.<u></u><u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)"><u></u> <u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)">In Europe I believe the CE regulates devices for general safety and efficacy, as well as electrical safety specifically, combining the roles of FDA and UL.<u></u><u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)"><u></u> <u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)">Many EEG systems are sold in the USA with FDA clearance for clinical use and that have up to 256 channels with electrode caps or nets that use variants of the
10-20, 10-10, or 10-5 system, or uniform geodesic spacing as the EGI produces. Some of these have active electrodes. Now it may be the case that the FDA does not clear any active electrode system for clinical use in the USA, but that has no impact on using
them for research, as your IRB should take care of assuring their electrical safety.<u></u><u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)"><u></u> <u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)">-Jeff Eriksen<u></u><u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)">Portland, OR<u></u><u></u></span></p>
<p class="MsoNormal"><span style="font-size:11pt;font-family:Calibri,sans-serif;color:rgb(31,73,125)"><u></u> <u></u></span></p>
<p class="MsoNormal"><b><span style="font-size:10pt;font-family:Tahoma,sans-serif">From:</span></b><span style="font-size:10pt;font-family:Tahoma,sans-serif"> <a href="mailto:eeglablist-bounces@sccn.ucsd.edu" target="_blank">eeglablist-bounces@sccn.ucsd.edu</a> [mailto:<a href="mailto:eeglablist-bounces@sccn.ucsd.edu" target="_blank">eeglablist-bounces@sccn.ucsd.edu</a>]
<b>On Behalf Of </b>Makoto Miyakoshi<br>
<b>Sent:</b> Thursday, March 26, 2015 10:31 AM<br>
<b>To:</b> Friedman Doron<br>
<b>Cc:</b> <a href="mailto:eeglablist@sccn.ucsd.edu" target="_blank">eeglablist@sccn.ucsd.edu</a><br>
<b>Subject:</b> Re: [Eeglablist] active electrodes<u></u><u></u></span></p><div><div class="h5">
<p class="MsoNormal"><u></u> <u></u></p>
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<p class="MsoNormal">Dear Doron,<u></u><u></u></p>
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<p class="MsoNormal"><u></u> <u></u></p>
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<p class="MsoNormal">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.<u></u><u></u></p>
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<p class="MsoNormal"><u></u> <u></u></p>
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<p class="MsoNormal">Makoto<u></u><u></u></p>
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<p class="MsoNormal"><u></u> <u></u></p>
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<p class="MsoNormal">On Mon, Mar 23, 2015 at 2:10 PM, Friedman Doron <<a href="mailto:doronf@idc.ac.il" target="_blank">doronf@idc.ac.il</a>> wrote:<u></u><u></u></p>
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<p class="MsoNormal">Hi,<u></u><u></u></p>
<p class="MsoNormal"> <u></u><u></u></p>
<p class="MsoNormal">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"> <u></u><u></u></p>
<p class="MsoNormal">Thx<u></u><u></u></p>
<p class="MsoNormal"> <u></u><u></u></p>
<p style="margin-right:0in;margin-left:0.5in;margin-bottom:0.0001pt">
-<span style="font-size:7pt"> </span>d<u></u><u></u></p>
<p class="MsoNormal" dir="RTL" style="text-align:right;direction:rtl">
<span dir="LTR"> <u></u><u></u></span></p>
<p class="MsoNormal">Dr. Doron Friedman<span lang="AR-SA" dir="RTL"><u></u><u></u></span></p>
<p class="MsoNormal">Senior Lecturer<u></u><u></u></p>
<p class="MsoNormal">Sammy Ofer School of Communications<u></u><u></u></p>
<p class="MsoNormal">Office phone number:
<a href="tel:%2B972-9-9527654" target="_blank">+972-9-9527654</a><u></u><u></u></p>
<p class="MsoNormal">Room C225, Sammy Ofer building<u></u><u></u></p>
<p class="MsoNormal">The Interdisciplinary Center, Herzliya<u></u><u></u></p>
<p class="MsoNormal">PO Box 167, 46150<u></u><u></u></p>
<p class="MsoNormal"> <u></u><u></u></p>
<p class="MsoNormal">Director, Advanced Reality Lab<u></u><u></u></p>
<p class="MsoNormal"><a href="https://urldefense.proofpoint.com/v2/url?u=http-3A__avl.idc.ac.il&d=AwMFaQ&c=5aMxbibQyX6B-W2mpD2HYH5lwK3h7A1hIsNQieXCZKA&r=RW9gWwlQ_echeF9GoAB-bw&m=6L-dSIt9h2vweNlBzFyy6iquomgFXIF83rBhD7AQxz4&s=ToDqVhPrmroKCdS7-IP_lg46ljd4qjfvUrYM1vkgIAo&e=" target="_blank">http://avl.idc.ac.il</a><u></u><u></u></p>
<p class="MsoNormal" dir="RTL" style="text-align:right;direction:rtl">
<span dir="LTR"> <u></u><u></u></span></p>
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<p class="MsoNormal"><br>
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<u></u><u></u></p>
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<p class="MsoNormal"><u></u> <u></u></p>
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<p class="MsoNormal">-- <u></u><u></u></p>
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<p class="MsoNormal">Makoto Miyakoshi<br>
Swartz Center for Computational Neuroscience<br>
Institute for Neural Computation, University of California San Diego<u></u><u></u></p>
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</blockquote></div><br><br clear="all"><div><br></div>-- <br><div class="gmail_signature"><div dir="ltr">Makoto Miyakoshi<br>Swartz Center for Computational Neuroscience<br>Institute for Neural Computation, University of California San Diego<br></div></div>
</div></div>