From: yaniv_vi (yaniv_vi_at_yahoo.com)
Date: 2001-12-23 09:36:28
hi doug , and all
--- In buildcheapeeg_at_yahoogroups.com, Doug Sutherland <wearable_at_earthlink.net> wrote:
> 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.
basicly i agree with that aproach - we need to design it to be
conforming to IEC standards . that way we get :
1. a safe design - for the plain user .
2. optional use in future by clinicans .
so now there are 2 challenges :
1. how we make a low cost device that would conform to IEC ?
i look at the open source of hardware not as an issue ,
because we get to a point of we have a version , and this version
we'll test / do something ? , and then would claim "IEC"
only on it , if you change it , you don't get iec !pretty simple .
2. same idea in software , at some point we would need to take a
a version , make it throught some tests , and claim it's
verified .
so i try to get to a list of what ways we should take after readin
all this posts .if anyone disagree , please tell .
1. h.w. should comply to iec ( and i add with minimal requirement of
expensive testing ) .
2. if we form an ngo ( non profit group ) , it would be really
helpfull .
3. we should aim , with an IEC design to common people ,
as our main goal .
but as a secondary goal we could think/work/make contacts ,
on the goal goin from there to fda approved design , somehow.
but for now , only as secondary goal .
4. contact with small elctronics mfr. companies would be helpfull .
5. of course legal help would be required .
i think the most important step at this time is to get a ngo , at the
states , or europe , preferably at the states.
so is there someone from u.s. who would like to help in this ?
sincerly
yaniv
>
> -- Doug
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