[Eeglablist] active electrodes

Eriksen, Jeffrey :LGS Neurodiagnostics JEriksen at LHS.ORG
Thu Mar 26 11:09:20 PDT 2015


Any and all:

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.

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.

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.

-Jeff Eriksen
Portland, OR

From: eeglablist-bounces at sccn.ucsd.edu [mailto:eeglablist-bounces at sccn.ucsd.edu] On Behalf Of Makoto Miyakoshi
Sent: Thursday, March 26, 2015 10:31 AM
To: Friedman Doron
Cc: eeglablist at sccn.ucsd.edu
Subject: Re: [Eeglablist] active electrodes

Dear Doron,

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.

Makoto

On Mon, Mar 23, 2015 at 2:10 PM, Friedman Doron <doronf at idc.ac.il<mailto:doronf at idc.ac.il>> wrote:
Hi,

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?

Thx


-          d

Dr. Doron Friedman
Senior Lecturer
Sammy Ofer School of Communications
Office phone number: +972-9-9527654<tel:%2B972-9-9527654>
Room C225, Sammy Ofer building
The Interdisciplinary Center, Herzliya
PO Box 167, 46150

Director, Advanced Reality Lab
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--
Makoto Miyakoshi
Swartz Center for Computational Neuroscience
Institute for Neural Computation, University of California San Diego
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