Navigation Links
A Good Cigar May Be a Smoke, But a Gun Is Not a Medical Device, FDA Says in Response to Gunmaker
Date:12/8/2008

WASHINGTON, Dec. 8 /PRNewswire-USNewswire/ --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."

(http://www.snowflakesinhell.com/2008/12/03/hoisted-on-their-own-petard/)

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.

Visit the Brady Campaign website at www.bradycampaign.org. For continuing insight and comment on the gun issue, read Paul Helmke's blog at www.bradycampaign.org/blog/.

Contact: Peter Hamm, 202-898-0792, phamm@bradymail.org


'/>"/>
SOURCE Brady Campaign to Prevent Gun Violence
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Filtered Cigarettes Blamed for Huge Rise in Type of Lung Cancer
2. Penn School of Medicine receives $2.3 million to study biomarkers of cigarette smoke exposure
3. President Bush Should Protect Kids, Not Big Tobacco By Signing Bill to Increase Cigarette Tax, Fund SCHIP
4. Presidents Veto of Bill to Increase Cigarette Tax, Fund SCHIP Benefits Big Tobacco at Expense of Americas Kids
5. New Report: Increasing Oregons Cigarette Tax Will Reduce Smoking, Save Lives and Save Money
6. Congress Should Redouble Efforts to Increase Federal Cigarette Tax
7. New Report: Increasing Marylands Cigarette Tax Will Reduce Smoking, Save Lives and Save Money
8. Nicotine addiction slashed in test of new cigarette smoking strategy
9. Nicotine-Reduced Cigarettes Could Boost Quitting
10. Decreasing access to cigarettes for youth in the Minnesota Adolescent Community Cohort Study
11. New neuroimaging study identifies brain signature for cigarette cravings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... ... is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience ... Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is ...
(Date:6/24/2016)... Norcross, Georgia (PRWEB) , ... June 24, 2016 ... ... Year” awards today at the Clinical Decision Making in Emergency Medicine conference in ... who have authored journal articles published in Emergency Medicine Practice and ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone ... executive with extensive sequencing and genomics experience, as Vice President of North American Capital ... will be responsible for leading the sales team in the commercialization of the HTG ...
(Date:6/24/2016)... ... June 24, 2016 , ... Finally, a bruise cream ... procedures, dermaka cream can be incorporated into the post-surgical treatment plans of a variety ... , dermaka cream is very effective for bruising and causes a rapid resolution ...
(Date:6/24/2016)... ... 2016 , ... SpiritQuest Sedona Retreats, located in Arizona has re-located to 75 ... sites: Cathedral Rock, Airport Mesa, and Boynton Canyon. The new retreat center ... well as the Sedona Rouge, both popular accommodations for SpiritQuest clients. The Medicine ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
Breaking Medicine Technology: