Re: medical guns!

["Michael Simpson" <mikie.simpson () gmail com>]

On 12/9/08, Larry Seltzer <larry () larryseltzer com> wrote:
> http://www.google.com/hostednews/ap/article/ALeqM5gX8fvj4MkM30m7rPfghQ_I
> NA2qfgD94UQUEG1
>
> FDA nixes proposed 'prescription pistol'
>
> By RICARDO ALONSO-ZALDIVAR - 19 hours ago
>
> WASHINGTON (AP) - It could have been the world's first prescription
> pistol. The single-bullet Palm Pistol set the Internet abuzz with
> speculation that Medicare might even pay for the elderly and disabled to
> pack heat.
>
> But Monday the Food and Drug Administration said the Palm Pistol doesn't
> have a shot of being listed as a medical device, and revoked the
> registration issued to its inventor only last week.

When i worked for a large clinical research organisation as a medical
advisor one way of attaining automatic FDA approval for a "medical
device" was to apply for a CE mark within europe. Once this was
granted the FDA would pretty much rubber stamp its approval for the US
market.

That would be an interesting trial to design.

mike
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