We received a statement this evening from Constitution Arms, the manufacturer of Palm Pistol, “an ergonomically novel self defense handgun designed for seniors, disabled and others with limited manual dexterity”, that the FDA has rescinded its registration of the device.
From Matthew Carmel, president of Constitution Arms:
Based upon agency information, correspondence and verbal instructions, we were led to believe the Palm Pistol was classified as a “device,” were given specific listing instructions, assigned Product Code ILT corresponding with “Recreational Adapter” and identification of the device as a “Daily Activity Assist Device” in accordance with 21 CFR 890.5050, and accordingly informed we had authority to begin marketing it as such a “device.” At no time did we claim the device was “approved” by the FDA, as erroneously reported in the press. We did make every effort to correct this when extended the courtesy of an inquiry.
We believe the Palm Pistol serves a medical function and may appeal this cancellation of our registration and listing made in good faith. However, this has no effect upon our plan to design and produce the Palm Pistol.
From a press statement issued by the FDA:
The U.S. Food and Drug Administration has determined that the Palm Pistol, manufactured by Constitution Arms in [Maplewood, NJ] is not a medical device under the Federal Food, Drugs, and Cosmetic Act.
The manufacturer registered and listed the product in the FDA’s electronic database on Dec. 2, 2008. Because the FDA has determined the product is not a medical device under section 201(h) of the Act, FDA is cancelling the registration and will return its registration fee.
It appears that Constitution Arms registered the company and listed the Palm Pistol as a “recreational adaptor,” which may be a daily assist device under 21 CFR 890.5050. However, registration and listing does not constitute an admission, agreement or determination that a product is a device within the meaning of section 201(h) of the Act. The FDA has determined that the company’s listing was in error.