WASHINGTON — 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 on 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.
"The FDA has determined the product is not a medical device," the agency said in a statement.
The inventor is crying foul. "I would assume it's due to political pressure," said Matthew M. Carmel, from Maplewood, N.J. He said he's researching a possible appeal.
Medicare, the giant health care program for seniors and the disabled, would never have covered guns for grandmas anyway. "Medicare will not cover it because there is no approved category for weapons," said spokesman Peter Ashkenaz. "So it would not be viewed as reasonable and necessary."
Carmel said the elderly and disabled are easy targets for criminals, and the Palm Pistol could be an equalizer. Shaped like an oval, it fits in your palm. The barrel sticks out through your fingers. And instead of pulling a trigger, you push down on a button with your thumb. No working models exist yet, Carmel added.
But he said he wanted to start advertising to seniors, so he called the FDA and was advised to register his company, Constitution Arms, as a medical device facility and list the Palm Pistol as a "recreational adaptor." The registration seemed to go through without any problems.
FDA spokeswoman Siobhan DeLancey said Carmel apparently got some bad advice from a representative of the agency.
And maybe he should have paid more attention to the fine print on the registration notice. It said: "Registering ... does not, in any way, constitute FDA approval of your facility or your devices."
An earlier version of this article reported that the FDA had accepted the Palm Pistol as a medical device, based on last week's registration.
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