A Gun Is Not A Medical Device, FDA Says In Response To Gunmaker

Main Category: Public Health
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 09 Dec 2008 - 7:00 PDT

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The headlines were attention-grabbing. Discovery News wrote "FDA Approves Handgun for the Handicapped." The website NowPublic wrote "FDA Certifies Handgun as 'Medical Device." Medgadget , which calls itself "the internet journal of emerging medical technologies," wrote "Medicare to Cover Prescription Handguns?"

The New Zealand Herald wrote "A U.S. gun company will market a pistol to elderly Americans that will be subsidi[z]ed by the government in the same way as a wheelchair or walking frame." FOX News wrote the gun's manufacturer "says it's had it certified by the FDA as a 'Class I Medical Device.' That means doctors could prescribe the handgun to qualified patients, who would then have some or all of the cost reimbursed by Medicare or private insurance."

The U.S. Food & Drug Administration says otherwise.

After a flurry of calls generated by the manufacturer of the Palm Pistol, a single-shot 9mm handgun that rests in the palm and fires when squeezed, the FDA told the Brady Campaign to Prevent Gun Violence on Monday that it certainly had not approved the device. Shortly after the Brady organization contacted FDA, the agency issued a statement saying "the U.S. Food and Drug Administration has determined that the Palm Pistol, manufactured by Constitution Arms, 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 canceling the registration and will return its registration fee."

Matt Carmel, CEO of Constitution Arms in Maplewood, New Jersey and inventor of the device, may be confused by this. Before the FDA's announcement, he was quoted on gun blog SnowflakesinHell.com as saying: "All the 'experts' said the Palm Pistol would never be classified as a medical device by FDA and I proved them wrong. Now all the experts are saying there is no way this will be reimbursable under Medicare. Well, we shall see about that!" And the gun blogger, who calls himself Sebastian, responded "the progressives created this system, and now we have hijacked it to help people buy guns! Matt has hoisted them on their own petard." (See here)

As the nation's largest, non-partisan, grassroots organization leading the fight to prevent gun violence, the Brady Campaign, with its dedicated network of Million Mom March Chapters, works to enact and enforce sensible gun laws, regulations and public policies. The Brady Campaign is devoted to creating an America free from gun violence, where all Americans are safe at home, at school, at work, and in our communities.

For continuing insight and comment on the gun issue, read Paul Helmke's blog at http://www.bradycampaign.org/blog.

Brady Campaign