From: Rob Kall (smile_at_compuserve.com)
Date: 2001-04-30 12:50:18
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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