FDA Denies “˜Palm Pistol’ Medical Device Coverage

The world’s first prescription pistol was denied registration on Monday by the Food and Drug Administration.

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 now the FDA says the Palm Pistol doesn’t stand a chance of being listed as a medical device.

The agency released a statement saying the product is not a medical device and now its 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.

But most experts believe Medicare, the giant health care program for seniors and the disabled, would have never covered guns for the elderly in the first place.

“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.”

The elderly and disabled are easy targets for criminals, said Carmel, 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. Carmel added, however, that no working models currently exist.

But when he decided to start advertising to seniors, he contacted 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.

But Siobhan DeLancey, an FDA spokeswoman, said Carmel apparently got some bad advice from an FDA representative.

Had Carmel paid closer attention to the registration notice he filled out, he would have noticed it’s warning: “Registering … does not, in any way, constitute FDA approval of your facility or your devices.”

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