[Eeglablist] active electrodes

[Geoff Mackellar]

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.

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).
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.

Geoffrey Mackellar PhD
CEO, Emotiv Research Pty Ltd
Co-founder and CTO, Emotiv, Inc.
geoff at emotiv.co
www.emotiv.com
www.emotiv.co

On Fri, Mar 27, 2015 at 4:31 AM, Makoto Miyakoshi <mmiyakoshi at ucsd.edu>
wrote:

> 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> 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
>>
>> Room C225, Sammy Ofer building
>>
>> The Interdisciplinary Center, Herzliya
>>
>> PO Box 167, 46150
>>
>>
>>
>> Director, Advanced Reality Lab
>>
>> http://avl.idc.ac.il
>>
>>
>>
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>
>
>
> --
> Makoto Miyakoshi
> Swartz Center for Computational Neuroscience
> Institute for Neural Computation, University of California San Diego
>
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