Palm Pistol Inventor Calls FDA's Decision 'Political'
FDA: Firearm For Elderly, Disabled Not A Medical Device
Last Edited: Wednesday, 10 Dec 2008, 2:28 AM EST
Created: Wednesday, 10 Dec 2008, 2:28 AM EST
Should the Palm Pistol be considered a medical device?
By ANTHONY BARTKEWICZ
Should a gun be considered a medical device? The inventor of the Palm Pistol
claims that the Food and Drug Administration said "yes," then changed its mind.
The Palm Pistol is a single-shot firearm designed for the elderly or disabled who may lack the manual dexterity or strength to fire a regular gun in moments of self-defense. The firing pin is released by pressing a button with the thumb rather than the index finger. (View a diagram of the Palm Pistol mechanism here
The Bureau of Alcohol, Tobacco and Firearms classified it as a standard pistol, but inventor Matthew Carmel wanted to spread the word to senior citizens. 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."
On Monday, the FDA said it had determined the Palm Pistol was "not a medical device," the Associated Press reported
Carmel said, "I would assume it's due to political pressure...I most certainly do see this as a Second Amendment issue."
Carmel explained that seniors and the disabled are at a greater risk of being victims of violent crime while often simultaneously being at an economic disadvantage that leaves them unable to afford firearms for lawful self-defense.
"If the FDA were to permit my design to be classified as a medical device, at the very least, it may have been possible for seniors and disabled to request partial reimbursement from private health insurance companies," Carmel said in an e-mail interview.
"I also would have argued that the cost of this adaptive aid should be covered by Medicare. I find it quite ironic that certain elements of the political spectrum demand more protection for the weak, yet when someone steps up to the plate to provide that protection, to empower the weak from predators, they somehow cast a blind eye to their needs," he added.
A spokesman for Medicare told the Associated Press that the program would not cover the Palm Pistol because there is no approved category for weapons and, as such, "it would not be viewed as reasonable and necessary."
The Palm Pistol is not yet commercially available, though it is possible to reserve a preorder through the official site. Carmel says he's received "hundreds of e-mails, from all over the world, with inquiries," and that the FDA's decision has no impact on his ability to market the Palm Pistol.
"Unfortunately," he wrote, "it has a great impact on seniors and the disabled who now may be less able to afford a tool that could be used to lawfully defend their own lives and those of their loved ones."