From: sood_s_at_y...
Date: 2001-04-30 13:58:20
Thanks Mr. Kall,
well, I would check that (focusedtechnology F1000 ) website.
Your suggestion seems to be practical enough to be implemented in
certain cases. Yes, we can classify/project it as an educational
tool. But here the users could be psychologists, neurologists apart
from those interested in the instrument (indeed for them the device
is really a non-clinical one).
Yes, the goal is definitely to create an affordable device and I feel
that the cost in developing/producing a device is not only due to
the design part but also the safety testing and certification
(another accredited agency in US says that they certified few EEGs
and the cost was around $75000 US-discouraging :-( ). We can indeed
forego the certification (Ooops ! in this case, I would loose my role
in the group) part instead as U said we can navigate around the
regulations/safety standards.
FYI, the following are the ways to get the product certified:-
A. We can test the product ourself and 'declare' that the product
complies to a particulr standard.
B. We test the product at any 'accredited' laboratory which is
acceptable in the countries where the product is to be used.
C. We have to test the product in laboratories specified by the
authorities in the relevant country.
If at all we are working towards a low cost device, Option "A." is
fine. We carry out the tests ourselves and make those interested in
the device, sure about the safety at the coarse level. But in this
case we would have to procure the test equipment.
Another option could be to get the device tested as per option "C."
here we can zoom-in into a counry where the testing is not so
expensive. That certification could be used to some extent for
getting the shade of quality in the instrument. Here in India, we
have BIS (Bureau of Indian Standards as the National standardisation
agency) and they too follow the IEC 601.1 equivalent safety
standards , infact the same standards re-written with permission from
IEC. I am yet to now the cost that is involved in getting an EEG
certified. Would do that in a week as I would have to go to a lab
personally (email culture is not down to the Govt. department's
functioning). I hope U would bear that delay.
So if such an arrangement is acceptable, then we have a locost
solution, I gues that the costs would not be more than $10,000 US.
that's a wild guess towards a higher side, I got biased owing to the
figures I got from US concultants.
Anyway lets wait , I am still working towards testing in US. Who
knows we might get a agency that's ready to volunteer. Wow ! that's
what I call as "height of being an optimistic." I am one.
Could get the website the URL is :-
http://www.focused-technology.com
Still hopeful.
best regards,
Sanjay P. Sood
INDIA.
--- In buildcheapeeg_at_yahoogroups.com, Rob Kall <smile_at_compuserve.com> wrote:
> Message text written by INTERNET:buildcheapeeg_at_yahoogroups.com
> >
> Which geographical segment/user base are we aiming at?
> -If its only US, then we are virtually without any option.
> -If its Europe, something cheaper could be tried.<
>
> I would guess that 95% of the existing biofeeback equipment sold in
the US has gone through the 601.1 testing, if it costs that much.
Most companies already in existence are too small to be able to
afford that much money
> Take a look at the focusedtechnology F1000 (not sure of exact URL
but you;ll find it fast in a search. They've been selling for years
without any such tests or registrations.
>
> They do so by not claiming to be a clinical device, but rather, an
> exucational tool. If the goal is to create an affordable device,
then it will be necessary to navigate AROUND regulations, not
attempt to dive into the middle of the commercial flow.
>
> For exampl., to my understanding, much of the eligibility for FDA
> regulation is determined by how your product descriptions read. If a
> medical description, then FDA registration is required. If not,
then it is
> less likely that FDA regulation is needed.
>
> I am not a lowyer, and this is not legal advice. But that's the way
I've
> seen it handled in my 23 years in the biofeedback business and 30
years in
> the field of self regulation..
>
> Rob Kall
> Futurehealth, Inc.
> 211 N. Sycamore St., Newtown, PA 18940 215-504-1700, fax 215-860-
5374
> www.futurehealth.org
> 10th annual Winter Brain Meeting February 7-11, Miami Florida
> "We should treat our minds, that is, ourselves-- as innocent and
ingenuous
> children, whose guardians we are, and be careful what objects and
what
> subjects we thrust on their attention." Thoreau, Life Without
Principle
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