When is a gun a medical device?

Dec 9 2008

Reports from the United States that authorities there have approved a handgun designed for those crippled by conditions such as arthritis and muscular dystrophy have given rise to confusion and debate.

Apparently the single-shot 'Palm Pistol' had been reportedly approved by the U.S. Food and Drug Administration (FDA) as a Class 1 Medical Device, meant for people crippled by conditions that render them too weak to operate normal handguns.

The reports say the FDA accepted the conceptual, ergonomic 9mm handgun developed by the company Constitution Arms as a Class 1 Medical Device.

Constitution Arms says the Palm Pistol, is an adaptive tool that allows someone otherwise incapable of handling a revolver or semi-automatic weapon to operate one and is a symmetrical, ambidextrous instrument made of stainless steel which holds a single cartridge.

It is reportedly loaded by pressing a button and for the gun to be fired, two mechanical safeties must be depressed with the fingers on either side of the barrel before the trigger, located on the top and bottom of the gun, is pressed by the thumb.

The company says the Palm Pistol is both a medical device and a firearm and they already have orders for 70 - the pistol will cost around $300.

However according to the FDA, despite the headlines in the media, it has not approved the gun which is not a medical device under the Federal Food, Drugs, and Cosmetic Act.

Constitution Arms it seems registered and listed the product in the FDA's electronic database on December 2nd, 2008 and because the FDA has determined the product is not a medical device the organisation has cancelled the registration and will return the registration fee.