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:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... two panels at the Advanced ERISA Benefit Claims Litigation seminar in Chicago, Illinois. ... the Administrative Record, The majority of cases litigated under ERISA involve claims for ...
(Date:3/24/2017)... ... March 24, 2017 , ... Empower Brokerage, ... their training and leads programs. , In February, 2017, Empower Brokerage introduced their ... Performance Partners is designed to teach how to maximize their sales efforts, as ...
(Date:3/24/2017)... , ... March 24, 2017 , ... “Vintage and Harvest ... retired minister and college Bible teacher residing in North Carolina with his wife, Anna ... have blessed them with six grandchildren. David is also the author of “Shadow and ...
(Date:3/23/2017)... , ... March 23, 2017 , ... A recent report ... entry into teacher preparation programs. The NCTQ report suggests, based on a review of ... would significantly improve teacher quality in the U.S. It argues that this higher bar ...
(Date:3/23/2017)... ... 23, 2017 , ... PAINWeekEnd (PWE) Oklahoma City, on April ... will be an educational and exciting program providing busy clinicians and allied healthcare ... pain. , Oklahoma is in a healthcare crisis. The state ranks 46th in ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... -- Mosaic Life Care, based in St. Joseph, Missouri , has ... of 58 clinics, located in 22 cities, and its flagship St. Joseph Medical Center. ... the delivery of health care to its patients, including the insurance, billing and collections ... ... Mosaic Life Care St. Joseph Medical Center ...
(Date:3/23/2017)... Executive Summary ... primary research (inputs from industry experts, companies, stakeholders) ... the analysis of global heart valve devices market ... Replacement Procedure By Technique (Mechanical, Bioprosthetic, Transcatheter Aortic ... Balloon Valvuloplasty, Transcatheter Mitral Valve Repair (TMVR)), By ...
(Date:3/23/2017)... March 23, 2017 ... Healthcare disease pipeline guide Primary Hyperoxaluria - Pipeline ... Primary Hyperoxaluria (Genito Urinary System And Sex Hormones) ... condition characterized by recurrent kidney and bladder stones. ... called oxalate. Symptoms include blood in the urine, ...
Breaking Medicine Technology: