FDA Shoots Down Handgun as Approved Medical Device

FDA Shoots Down Handgun as Approved Medical Device
By Todd Neale, Staff Writer, MedPage Today
Published: December 11, 2008


ROCKVILLE, Md., Dec. 11 -- Faster than a speeding bullet, the FDA disapproved a tentative registration of a handgun as a medical device.

An embarrassed FDA conceded the handgun was given an automatic temporary designation as a medical device via an Internet registration. But the label was immediately revoked after a review. FDA marketing approval was never issued.


The agency said in a terse statement that it had "determined that the Palm Pistol, manufactured by Constitution Arms, is not a medical device under the Federal Food, Drug, and Cosmetic Act."


According to the Palm Pistol Web site, the gun is "ideal for seniors, disabled, or others who may have dexterity limitations or difficulty sighting and controlling a traditional revolver or semi-automatic pistol."


The gun maker submitted an Establishment Registration on Dec. 2, listing the product as a "recreational adaptor" using the online registration system of the FDA's Center for Devices and Radiological Health.


Upon review, the agency canceled the registration and returned the fee to Constitution Arms.


"Registration and listing does not constitute an admission, agreement, or determination that a product is a device with the meaning of section 201(h) of the Act," the statement said. "The FDA has determined that the company's listing was in error."


Some media outlets interpreted the original registration as evidence that the Palm Pistol was approved as a medical device and that it might become covered by Medicare.


However, according to an FDA spokesperson, manufacturers that list their products as Class I devices -- as Constitution Arms did -- do not necessarily have agency approval or clearance for marketing.


The registrations are not automatically reviewed before acceptance, the spokesperson said.


The weapon -- which holds a single 9-mm round -- is gripped in the palm of the hand and held in a fist with the barrel extending between the middle and ring fingers. Two safeties, one each on the top and bottom of the gun, must be pressed before the gun can be fired using the thumb.


Additional medical indications included on the Palm Pistol Web site are "arthritis; peripheral neuropathy caused by chemotherapy, infection, traumatic injury or diabetes; phalangeal amputations-fusions-fractures; distal muscular dystrophy; multiple sclerosis, carpal tunnel syndrome, Raynaud's syndrome; ganglion cysts; side effects of certain medications; and inclusion body myositis."


The FDA spokesperson would not comment directly on the medical usefulness of the Palm Pistol but said, "According to federal regulation, a daily assist device is a product that has been modified or adapted to help a medical patient perform a specific function. The FDA has several product groups for these devices -- examples include certain medication reminders, eating utensils, and recreational adaptors. There are no firearms in this category."


Palm Pistol said it is exploring an appeal of the FDA's decision.