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:10/25/2014)... 24, 2014 (HealthDay News) -- October,s shorter, darker days ... affective disorder, according to an expert. People ... feel overly tired, lack motivation and even have trouble ... lead to suicide, said Dr. Angelos Halaris, a professor ... Loyola University Chicago Stitch School of Medicine. "Seasonal ...
(Date:10/22/2014)... Medical Solutions , the ... to announce that our co-founder and CFO, Scott ... Staffing 100 for 2014. Anderson was also named ... people in the staffing industry,” in 2013.     , ... healthcare staffing company in the U.S., was named ...
(Date:10/22/2014)... TUESDAY, Oct. 21, 2014 (HealthDay News) -- The ... passengers arriving from Ebola-affected nations of West Africa ... screen them for infection with the virus. ... Jeh Johnson noted that 94 percent of air ... land at one of these five airports -- ...
(Date:10/22/2014)... 22, 2014 With the Affordable Care Act ... by the American Institutes for Research (AIR) finds that three ... use health insurance, but 42 percent say they are not ... before signing up for coverage. , The AIR survey found ... percent able to calculate correctly how much they owe for ...
(Date:10/22/2014)... Losing Weight Your Body’s Way , In a world ... face, it certainly can be difficult to choose the right ... favor by doing it the healthy way? Set aside the ... your body, exercise regularly, and choose foods with the most ... you need to exercise more and eat less. Despite the ...
Breaking Medicine News(10 mins):Health News:Dark Days Here for Folks With Seasonal Depression 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 3Health News:Passengers From Ebola-Affected Countries Must Land at Designated U.S. Airports 2Health News:Passengers From Ebola-Affected Countries Must Land at Designated U.S. Airports 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 2Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 3Health News:Many Americans Fail to Ask Basic Questions Before Signing Up for Health Insurance, National Survey Finds 4Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2
... new diagnostic technique capable of producing three-dimensional, in-depth ... number of women who are recalled for additional ... clinical trial being conducted at Emory University Breast ... annual meeting of the Radiological Society of North ...
... Procedures through the Belly Button: Scar-Free ... ... Nov. 28 Cleveland Clinic urologists recently,performed a series of ... repair), ileal ureter replacement, and psoas hitch uretero-,neocystostomy (for ureteral ...
... Medical Entrepreneurs is Only a Phone Call or ... care entrepreneurs,working outside the traditional health insurance payment ... computer software to make,medical care more accessible and ... the National Center for Policy Analysis (NCPA)., http://www.ncpa.org/pub/st/st305/st305.pdf ...
... Be Presented at 9:00 a.m. ... ... The Trade, Health and Environment,Impact Project, a collaboration of community organizations ... East Yard Communities for Environmental Justice, Center for,Community Action & Environmental ...
... and clinical ... development experience to Celator., PRINCETON, N.J., ... develop combination chemotherapies to,treat different types of cancer, today ... R. Appelbaum, M.D., head of the,University of Washington School ...
... that had the neurological disease, researchers say , WEDNESDAY, ... to a possible treatment for amyotrophic lateral sclerosis (ALS), ... a protein normally found in human cells into mice ... The team found that the treatment delayed symptoms and ...
Cached Medicine News:Health News:'Stereo' mammography takes breast imaging to a new dimension 2Health News:World Firsts by Cleveland Clinic Urologists 2Health News:NCPA Study: Government, Insurers Keep Medicine in Stone Age 2Health News:NCPA Study: Government, Insurers Keep Medicine in Stone Age 3Health News:Los Angeles Port Pollution, Int'l Trade & Goods Movement Conference This Weekend 2Health News:Frederick R. Appelbaum, M.D. and Ross C. Donehower, M.D. Join Scientific Advisory Board of Celator(R) Pharmaceuticals 2Health News:Cell Protein Might Help Treat ALS 2
(Date:10/22/2014)... October 22, 2014 A new ... Market (Product type, Form, End user, Application and Geography) ... Analysis, Research, Report, Opportunities, Segmentation and Forecast, 2013 - ... market. Based on key trends tracked, it is anticipated ... $7.9 billion by 2020, registering a CAGR of 6.2% ...
(Date:10/22/2014)... YARDLEY, Pa. , Oct. 22, 2014 /PRNewswire/ ... of their animal health medications, a Global Pharmaceutical ... and Antares serialization technology and turnkey solution to ... Photo - http://photos.prnewswire.com/prnh/20141021/153438 ... The product that was serialized and aggregated by ...
(Date:10/22/2014)... , Oct. 21, 2014   BioNano ... the latest genomics research centers to purchase an ... Institute, the National Cancer Institute (NCI), NIH Intramural ... Center). Before Irys, obtaining a comprehensive view of ... generation sequencing (NGS) does not deliver the scalability ...
Breaking Medicine Technology:Global Disposable Gloves Market Expected to Grow to $7.9 Billion by 2020 - Allied Market Research 2Global Disposable Gloves Market Expected to Grow to $7.9 Billion by 2020 - Allied Market Research 3Global Disposable Gloves Market Expected to Grow to $7.9 Billion by 2020 - Allied Market Research 4Xyntek and Antares Serialization Solution Protects Pets Too! 2BioNano's Irys System Adopted by Leading Genomics Centers for Comprehensive Detection of Human Genome Structural Variation 2BioNano's Irys System Adopted by Leading Genomics Centers for Comprehensive Detection of Human Genome Structural Variation 3
... Vantage Health (OTC BB: VNTH), ("Vantage"), ("company") announced today ... officials from the Ministry of Health and Social Welfare, ... all representing the United Republic of Tanzania ("URT") which ... formal Public Private Partnership ("PPP") Agreement between Vantage, its ...
... 2011 AAPC Physician Services ( www.aapcps.com ) recently ... to help busy medical practices simplify adherence to ... physician practice setting we are bombarded with compliance issues ... Schwebach, VP of AAPC Physician Services. "This compliance toolkit ...
Cached Medicine Technology:Tanzania Minister of Health, on Behalf of the Government, Promises Full Support to Vantage Health in the United Republic of Tanzania 2Tanzania Minister of Health, on Behalf of the Government, Promises Full Support to Vantage Health in the United Republic of Tanzania 3Tanzania Minister of Health, on Behalf of the Government, Promises Full Support to Vantage Health in the United Republic of Tanzania 4
... The S7 with Discrete Technology Coronary ... unmatched scaffolding. Proprietary Secure Technology stent ... pillows that partially encapsulate the stent ... Technology is designed to minimize balloon ...
Unique Radial Tandem Architecture Stent Design for enhanced flexibility and force characteristics....
Increased stent scaffolding at the proximal end gives optimal lumen support and 6F guide catheter compatibility and improved tracking offer excellent deliverability. Customized balloon lengths for ea...
For support, strength and control in your interventions, the RunWay Guide Catheter's large lumen and high-performance design represents a new era in guide catheters....
Medicine Products: