From: Doug Sutherland (wearable_at_earthlink.net)
Date: 2001-12-05 22:05:19
I took a closer look at Brainmaster's new web site ...
The BrainMaster is cleared by the FDA (K990538) for use
in clinical biofeedback applications. When sold for this
purpose, federal law restricts its use to or on the order
of a biofeedback practitioner. The approved indications
are for relaxation training using alpha waves.
http://www.brainmaster.com/generalinfo/clinicaluseinf/clinicaluseinf.html
Neurofeedback devices are only sold through or with
written permission of a professional biofeedback
practitioner.
http://www.brainmaster.com/productinfo/productinfo.html
Things have definitely changed. There used to be two
versions, one could be sold to anyone provided that they
agree not to use it for clinical purposes. Now it seems
to say you need permission from a practitioner to buy one.
The question is: are there regulations on this stuff,
in the USA, or UK, or Germany, or elsewhere?
FDA is a USA federal govt thing. I wonder if FDA approval
is actually required, or whether it's just desireable. It
would be interesting to look at others like WaveRider and
see if they have these FDA approvals/restrictions and
whether anyone can buy them.
It seems to me that if you want to sell anything at all
it would be wise to talk to a lawyer first ...
One other consideration. If a not-for-profit organization
was formed, then that organization can pay people to do
its work, like assembling units, and whatever. Just some
food for thought. How can a "virtual" organization ever
do manufacturing and sales?
-- Doug
This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:33 BST