Navigation Links
Report Urges New Review System for Medical Devices
Date:7/30/2011

By Amanda Gardner
HealthDay Reporter

FRIDAY, July 29 (HealthDay News) -- The U.S. Food and Drug Administration should scrap the system it uses to approve and regulate "moderate-risk" medical devices such as artificial joints and heart pacemakers, according to a highly anticipated federal report released Friday.

Instead, the FDA should come up with a legally sound process that ensures the devices go through more rigorous review before reaching the market place, according to the report by the U.S. Institute of Medicine (IOM).

At issue is the so-called fast-track 510(k) process of device approval, under which an estimated 90 percent of medical devices -- 3,000 -- reach the market each year. The process, approved by Congress in 1976, was created to approve medical devices if they are "substantially equivalent" to an existing device. While the system was originally designed as a temporary measure to "grandfather" devices already on the market, it has become the primary method for approving moderate-risk medical devices and implants.

The 510(k) system "does not determine a device to be safe or effective," according to the IOM report, which was commissioned by the FDA and is not binding. The IOM is a non-partisan group of scientific and medical experts that is part of the National Academy of Sciences.

The IOM report follows several widely publicized recalls of devices, including the recall last year of two faulty artificial hip systems that had been implanted in almost 100,000 patients.

The 510(k) approval process for medical devices is far more lax than the system used to approve new drugs, which must undergo extensive review in clinical trials before they are approved, and then "post-marketing" surveillance.

"It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," IOM committee chair Dr. David Challoner, emeritus vice
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Exercise Success for People Over 50: Reports of Improved Fitness, Circulation and Balance
2. New Report: The Internet Has More Influence Over Consumer Health Actions than Traditional DTC Channels
3. NationalCreditReport.com Reminds Consumers of Ways to Improve Credit Report and Score in 2010
4. Minnesota Department of Health Report: Nearly 6,000 Hospitalizations for COPD in 2007
5. Family Research Council: Planned Parenthood Report Oversexualizes Ten-Year-Olds, Undermines Parental Authority
6. New Report: $1 Cigarette Tax Increase Would Raise $418.8 Million for Texas and Cut Youth Smoking
7. New Report: $1 Cigarette Tax Increase Would Raise $18.6 Million for Montana and Cut Youth Smoking
8. New Report: $1 Cigarette Tax Increase Would Raise $24.8 Million for Wyoming and Cut Youth Smoking
9. New Report: $1 Cigarette Tax Increase Would Raise $43.3 Million for Utah and Cut Youth Smoking
10. New Report: $1 Cigarette Tax Increase Would Raise $113.9 Million for Colorado and Cut Youth Smoking
11. New Report: $1 Cigarette Tax Increase Would Raise $65.3 Million for Iowa and Cut Youth Smoking
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Report Urges New Review System for Medical Devices
(Date:5/4/2015)... (PRWEB) May 04, 2015 During 2015-2019, ... a 7.7% CAGR. Currently, the European and APAC probiotic ... while the North American probiotic market lags behind owing ... population. , The North American probiotic market is ... 58%), followed by Canada and Mexico. The North American ...
(Date:5/4/2015)... (PRWEB) May 04, 2015 Malibu ... oral antiseptic breath spray. KissSafe™ is the first ... a safer experience while adding fresh breath appeal. ... and effectively kills germs in the mouth and ... also contains ingredients that possess additional wellness benefits. ...
(Date:5/4/2015)... 04, 2015 In a continuing effort ... substance absue, Per Wickstrom, the founder of Choices Recovery ... and the “Salute to the Oscars” celebration held ... the top floor of the luxurious Beverly Hilton Hotel. ... producer of sustainable product placement in TV and film, ...
(Date:5/4/2015)... New York (PRWEB) May 04, 2015 ... as $2.4 billion to settle thousands of Actos lawsuits ... diabetes medication increases the risk that a patient will ... on April 28th, if 95% of those eligible for ... resolve nearly 9,000 bladder cancer cases currently pending in ...
(Date:5/4/2015)... 2015 Getting patients to work with ... is critical to achieving the “triple aim” of better ... this will require a shift in thinking from stakeholders ... health systems move beyond their traditional boundaries to reach ... the third live meeting of the ACO and ...
Breaking Medicine News(10 mins):Health News:North America Probiotic Market to Increase by 2019, Announces MicroMarketMonitor in Its New Research Report Recently Published at MarketPublishers.com 2Health News:80 Million Germs from Kissing - Introducing KissSafe™ 2Health News:Per Wickstrom Interviews TV and Film Star Carolyn Hennesy About Substance Abuse and Treatment 2Health News:Actos Lawsuit Settlement: Takeda Pharmaceutical Co. to Pay As Much As $2.4 Billion to Resolve Claims Alleging Actos Causes Bladder Cancer 2Health News:Actos Lawsuit Settlement: Takeda Pharmaceutical Co. to Pay As Much As $2.4 Billion to Resolve Claims Alleging Actos Causes Bladder Cancer 3Health News:AJMC’s ACO Coalition Explores the New Rules of Patient Engagement 2Health News:AJMC’s ACO Coalition Explores the New Rules of Patient Engagement 3Health News:AJMC’s ACO Coalition Explores the New Rules of Patient Engagement 4
... in collaboration with,Siemens(R), AxisThree(R), Inc. of Pacific Palisades, ... Technology into the,Plastic Surgery office of Dr. Steve ... XS-300(TM), is the first of its kind, and ... combined with,innovative proprietary software. The XS-300(TM) platform photographs ...
... launch of its redesigned web site at www.oci.com , ... ... to meet the needs of its customers and target market, OCI is ... The site features improved content, an enhanced look and feel, and easy ...
... percent savings on medical services and healthcare products. , ... ... -- Allsup announced today it is offering a new http://www.allsup.com/Health-Discount-Program.aspx/?=PRJ2 ... of people with disabilities gain access to discounted healthcare and ...
... prescription drug samples distributed to children may be unsafe, ... Alliance and Hasbro Children,s Hospital. The national study, the ... children, appears in the October 2008 issue of ... as researchers at Harvard Medical School and the Warren ...
... long way toward helping severely obese individuals improve their ... to researchers at the Duke Diet and Fitness Center. ... average, just under one hour of exercise per week, ... life. They also reported improvements in their ability to ...
... Extendicare Skilled Nursing Facilities Named In Wash. Lawsuit, ... with,additional allegations in the class action lawsuit against ... the state of Washington [see,list by city at ... in,United States District Court, Western Washington Division, in ...
Cached Medicine News:Health News:Plan Your Breasts in 3-D 2Health News:Information Management Solutions Provider OCI Announces Redesign of Corporate Web Site 2Health News:Allsup Introduces Health Discount Program to Millions of People with Disabilities 2Health News:Allsup Introduces Health Discount Program to Millions of People with Disabilities 3Health News:Free drug samples carry risks for children 2Health News:A little exercise goes a long way for severely obese 2Health News:Additional Allegations Filed Against Elder Care Operator 2Health News:Additional Allegations Filed Against Elder Care Operator 3Health News:Additional Allegations Filed Against Elder Care Operator 4Health News:Additional Allegations Filed Against Elder Care Operator 5
(Date:5/4/2015)... Calif., May 4, 2015  Xencor, Inc. (NASDAQ: ... engineered monoclonal antibodies for the treatment of autoimmune ... reported financial results for the first quarter ended March ... highlights. "Following our equity offering in ... million, we are in a strong financial position ...
(Date:5/4/2015)... , May 4, 2015 PTC Therapeutics, Inc. (NASDAQ: ... financial results for the first quarter ending March 31, 2015. ... this year. In our first full quarter since the commercial ... the first treatment for nonsense mutation Duchene Muscular Dystrophy. We ... number on treatment since our last earnings call," stated ...
(Date:5/4/2015)... Pa. , May 4, 2015 DePuy ... Dura Repair, the first commercially available biosynthesized dural ... Synthes CMF is a part of the DePuy Synthes ... is a tissue membrane that covers and protects the ... be cut to allow surgeons to access the brain. ...
Breaking Medicine Technology:Xencor Reports First Quarter 2015 Financial and Operating Results 2Xencor Reports First Quarter 2015 Financial and Operating Results 3Xencor Reports First Quarter 2015 Financial and Operating Results 4Xencor Reports First Quarter 2015 Financial and Operating Results 5Xencor Reports First Quarter 2015 Financial and Operating Results 6Xencor Reports First Quarter 2015 Financial and Operating Results 7Xencor Reports First Quarter 2015 Financial and Operating Results 8PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 2PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 3PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 4PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 5PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 6PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 7PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 8PTC Therapeutics Reports First Quarter 2015 Financial Results and Provides Corporate Update 9DePuy Synthes CMF Launches First Biosynthesized Cellulose-Based Dural Replacement For Neurosurgery 2DePuy Synthes CMF Launches First Biosynthesized Cellulose-Based Dural Replacement For Neurosurgery 3
... 20, 2011 One of Frantz Medical Group,s (FMG) ... has been awarded an Ohio Third Frontier grant to ... for penetrating through vascular Chronic Total Occlusions (CTOs), in ... Artery Bypass Graft (CABG).   VasoStar,s primary ...
... Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, ... Board and Chief Scientific Officer, will participate on a ... Conference on July 22nd, 2011, 10:30 am ET. The ... in Washington, D.C. on July 20-22, 2011, and will ...
Cached Medicine Technology:Frantz Medical Group Subsidiary, VasoStar, Awarded $1 Million Research Grant 2Frantz Medical Group Subsidiary, VasoStar, Awarded $1 Million Research Grant 3Chimerix to Present at Infocast's 9th Annual Biodefense Vaccines & Therapeutics Conference 2Chimerix to Present at Infocast's 9th Annual Biodefense Vaccines & Therapeutics Conference 3
... the only in-office test approved by the FDA ... BladderChek Test is a painless and non-invasive assay, ... elevated levels of NMP22 protein. Healthy individuals generally ... the urine. However, the level of NMP22 protein ...
Used for measuring rectal pressure during urodynamic studies. All-silicone construction provides maximum softness and biocompatibility for enhanced patient comfort. Supplied sterile in peel-open pack...
Used for suprapubic monitoring of bladder pressures. Suprapubic urodynamic studies avoid the effects of urethral catheterization and eliminate the need for a double bladder puncture. Supplied sterile...
... point-of-care (POC) diagnosis of patients with acute ... embolism. For use in doctors offices or ... counts, the Cardiac reader analyzer allows the ... D-Dimer from a single whole blood sample ...
Medicine Products: