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FDA ''approval'' of CES

Posted by pseudoname on November 12, 2005, at 9:23:29

In reply to Alpha-stim vs anxiety and depression, posted by RichardB on November 11, 2005, at 14:22:18

> If there was something, FDA approved...

Just to be clear, CES is *not* FDA-approved for the treatment of depression in the way that Prozac has been approved. To quote Larry Hoover's post from earlier this year:

<quote>
With respect to FDA approval, I'd like to make clear that this type of device is approved only because a substantially equivalent device was already in use prior to the enactment of medical device regulations in 1976. As such, the vendors of these devices only need to show that their product is not a novel type of device, and they circumvent proper oversight via a grandfather clause loophole. These devices are Class 3, which have the greatest likelihood of adverse effects or injury to the patient. That said, it's hard to tell just what these devices do, let alone how they could hurt.

Here's what the FDA has to say about Class 3 devices:
http://www.fda.gov/cdrh/devadvice/3132.html
<unquote>
http://www.dr-bob.org/babble/20050222/msgs/461863.html

That's not to say it won't help someone or isn't worth a try. Like so much in this area, it has simply not had proper evaluative studies. Reports in the Babble archives are mixed.


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poster:pseudoname thread:577828
URL: http://www.dr-bob.org/babble/alter/20051025/msgs/577994.html