From: Doug Sutherland (wearable_at_earthlink.net)
Date: 2001-12-21 04:46:45
Hi Yaniv,
> i don't understand one thing, if the brainmaster haven't
> passed fda tests until 1999, what kind of tests he had
> passed ? did he passed any tests before that?
I have no idea what, if any, tests were done. All I know
is what I have already said, all from observation on the
status of things when I bought one, and various web site
info including the FDA govt site.
> did he have any claims before that about safety?
Probably not. In fact I don't see claims about safety
now. I've been thinking heavily on this whole FDA thing.
I see approx 12-15 different low-cost EEGs on the market.
It looks like not all of them are FDA approved. Here are
some low-end EEG FDA approvals:
Lexicor NRS-2D (Oct/1996)
http://www.fda.gov/cdrh/pdf/k961645.pdf
Stoelting Autogenics AT62 (Feb/1997)
File is not online
Brainmaster 2E (May/1999)
http://www.fda.gov/cdrh/pdf/k990538.pdf
Stoelting Autogenics AT620-3 (Oct/2001)
http://www.fda.gov/cdrh/pdf/k012011.pdf
I don't see any FDA approvals for WaveRider or Procomp.
Lexicor makes POD (another low-cost EEG) and they don't
seem to have FDA approval for that but do for NRS-2D.
POD is cheaper that NRS-2D.
So it seems that not everyone is getting FDA approval
for EEGs. This leads to the question: why or why not
seek FDA approval? The mind machine FAQ explains some
good reasons why most mind machine manufacturers don't
seek EEG approval. My belief is that Brainmaster sought
FDA approval because it's main intention is for real
clinical use. They probably sought FDA approval so they
can make sure that they are accepted by practitioners.
The next question: should OpenEEG seek FDA approval?
Hard to answer. First of all, I doubt that OpenEEG can
do that in its current structure. The FDA is not very
likely to grant approval to a virtual organization. I
am just guessing here, but I think it would need to be
some kind of formal entity, like a company, or maybe
a not-for-property company. Somebody or some entity
needs to make the request and be responsible for the
actions in observance of FDA regulations. There needs
to be a name, address, etc on the application.
This is a really interesting "open hardware/software"
kind of issue IMO. How can a truly "open" development
ever be responsible for something like regulation? The
"open" nature makes it possible for almost anyone to
take the design and mess around with it. I would think
that the FDA would have a problem with that issue. One
company or entity can be responsible/accountable, but
an ad hoc collection of developers, who is accountable?
This is all speculation, but I am doubtful if we can
file with FDA without forming either a company or a
not-for-profit organization first.
I'm starting to think that shooting for FDA approval
is not a good idea for several reasons, at least in
the short-term. However, I think it would be a good
idea to design as if we were shooting for FDA approval,
ie following the IEC electrical standards etc. We may
not be FDA approved, but we could be "medical grade".
Then later, if we do want to shoot for FDA approval,
we will already be prepared.
-- Doug
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