Palm Pistol Inventor Calls FDA's Decision 'Political'

myfoxtwincities.com ^ | 12/10/08 | ANTHONY BARTKEWICZ/MyFoxNational

[ButThreeLeftsDo]

Some background...http://www.freerepublic.com/focus/f-news/2143359/posts

[null and void]

There's also a poll to FReep...

[ButThreeLeftsDo]

Yeah, and it’s pretty one-sided.....

[PeterPrinciple]

So he spoke with the FDA and was advised to register his company as a manufacturer of medical devices and list the pistol as a “daily activity assist device.”

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Depends what is is...........................

[null and void]

*shrug* It’s only 80:20, a Califorina court would cheerfully overturn an election that was that close.

[God Bless the Rocky Mountains]

Is it manufactured to assist the elderly due to a deficiency in standard hardware? Yes.

The FDA should certify it, but label it as a weapon. Which means there must be registration and licensing.

[thefrankbaum]

I don't think this thing is a medical device, any more than a derringer is. Of course, I believe people should be able to have pistols without restrictions in most cases, but I don't think doing an end-run around the law is the way to do it. I think, with the momentum we are carrying from Heller, we should fight these unconstitutional laws!

[saleman]

Kinda new here aren't you?

OK, I'll bite. Why must there be licensing and registration?

[InABunkerUnderSF]

Welcome to FR! Will you be staying?

It’s a gun. A gun should no more be subject to FDA regulation than a pair of scissors or a soda straw, both of which exist in modified form to enable their use by the elderly.

Why must there be “registration and licensing”?

[freespirited]

Carmel said, "I would assume it's due to political pressure.

While no federal agency is immune to political pressure and many prone to incompetence, in this case I have to agree with the FDA. The law defines what a "medical device" is, and this does not come close to meeting that definition. It is not involved in the diagnosis, prevention, or treatment of disease.

[ButThreeLeftsDo]

Exactly..

[Steamburg]

Looks like a medical device in the state of Washington. Do I need to explain a single shot?

[LiberConservative]

Looks like an Rx for suicide if you ask me. I think it's obscene.

[antiRepublicrat]

I don't think this thing is a medical device, any more than a derringer is.

I think it is a medical device under the definitions commonly used for this category. A medical device isn't necessarily something like a diabetes monitor or a pacemaker. It can be anything designed to mitigate the effects of a medical condition, IOW, give an aspect of normal life back to those who have lost it due to disease or infirmity. Wheelchairs give mobility back and braille typewriters give back the ability to write stuff you can read, so they are listed as medical devices. This mitigates the effects of disease on the ability to defend one's self, thus it is a medical device.

[Manly Warrior]

A firearm is a firearm just as a hammer is a hammer.

Use is determined by human behavior, not innate characteristics of the tool/object in question.

[Ruy Dias de Bivar]

Now, THIS is a palm pistol!

[antiRepublicrat]

and this does not come close to meeting that definition. It is not involved in the diagnosis, prevention, or treatment of disease.

The FDA says a medical device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure of any function of the body and which does not achieve its primary intended purpose through chemical action and which is not depended upon being metabolized for the achievement of its primary intended purposes."

Looking in there, this is intended for use in the mitigation of disease, namely when disease has rendered you unable to defend yourself with a regular firearm. It is a medical device.

[thefrankbaum]

So the sensors on urinals assist those with arthritis by not forcing them to reach up and flush? Drive-thrus help the morbidly obese by obviating the need for them to walk outside a vehicle to acquire food? You can argue ad absurdum for just about anything to meet that definition.

[antiRepublicrat]

A firearm is a firearm just as a hammer is a hammer.

This is a neurological hammer.

Not quite what you use to drive nails.