Re: FDA EEG Devices Guidance for 510(k) Content

From: JimmyB_101 (jiva_at_humboldt1.com)
Date: 2001-12-22 22:48:38

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> 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 Catch22 is that a lot of medical devices can only
be sold to qualified medical personnel/organizations.
It seems desirable to have a non-approved "hobby"
unit and (later?) a medically approved device for
professionals.

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