Navigation Links
Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtronic, Inc.
Date:10/22/2007

Filed in Support of Federal Pre-Emption in Riegel v. Medtronic, Inc.

WASHINGTON, Oct. 22 /PRNewswire-USNewswire/ -- Leading a group of concerned organizations, the Advanced Medical Technology Association (AdvaMed) filed a joint amicus brief Friday in the U.S. Supreme Court in the matter of Riegel v. Medtronic, Inc. arguing that the FDA should continue to be the sole regulator of medical devices. The brief states that no other legislative or regulatory entity is better positioned than the Food and Drug Administration to ensure the timely access to safe and effective medical devices.

The brief also contends allowing a state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies.

Joining AdvaMed are DRI, Medmarc Insurance Group and the Medical Device Manufacturers Association.

"The safety and efficacy of medical technologies are best determined by FDA scientists -- not by lawsuits filed in courtrooms throughout the country. It was the specific intent of the U.S. Congress that the FDA be responsible for the timely approval of safe and effective medical technologies. Encouraging states to insert state court liability suits into the process would undermine the science-based approach to approvals currently in place and would likely result in inconsistencies in standards and delayed access to products," said Christopher White, AdvaMed Executive Vice President and General Counsel.

Two previous rulings in this case have made clear that the Medical Device Amendments (MDA) to the Federal Food Drug and Cosmetic Act (FDCA) expressly provides for FDA's ultimate regulatory authority in these matters.

"We hope the Supreme Court re-affirms the two previous lower court rulings and prevents any erosion in FDA's existing regulatory approval authority," said White.

Other key arguments made in the filing include:

-- FDA currently exercises substantial
'/>"/>

SOURCE Advanced Medical Technology Association
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. A brief Intervention Might Help To Deal With Depression
2. Brief Intervention on HIV and Alcohol Risk Encourages Safer Sex
3. Multi billion-dollar suit filed against cell phone firm for causing brain tumours
4. Finland and India to interact and cooperate in the filed of telemedicine and biotechnology
5. Public Interest Litigation Filed Favoring Mineworkers Against Silicosis
6. Suit Filed Against Horrors of Psychiatric Ward in New York Hospital
7. Suit Filed Against Horrors of Psychiatric Ward in New York Hospital
8. Supreme Court Quashed Reservation Quotas For PG Medical Courses
9. Supreme Court Verdict Gives Hope to Striking Medicos
10. Supreme Court Warns Medicos of Contempt Action
11. Supreme Court Verdict Gives Hope to Striking Medicos
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... ... July 29, 2015 , ... TransFlip is an all ... drag & drop presets for FCPX, these transitions are easy to apply and modify ... to each transition. With over 60 preset styles, kinetic flipping panel animations are just ...
(Date:7/29/2015)... (PRWEB) , ... July 29, 2015 , ... The ... The project, which will by the end will cost the 501(c) organization nearly $1 ... Arizona’s recent anti-ligature requirements. , “We took it down to the studs,” said ...
(Date:7/29/2015)... ... 29, 2015 , ... HealthPostures ( https://healthpostures.com ), a sit ... an ergonomics specialty firm. Purpose of the partnership is to help strengthen and ... improve worker mobility, functionality and fitness levels. , Executives at HealthPostures and ...
(Date:7/29/2015)... , ... July 29, 2015 , ... ... the first dermatologist in Sarasota to be chosen by the manufacturer to offer ... offers the first injectable, non-invasive way to treat and eliminate double chin fat,” ...
(Date:7/29/2015)... ... July 29, 2015 , ... ITW Dynatec, along with Zip-Pak ... Powers is responsible for driving growth and innovation across ITW Dynatec’s worldwide customer ... as an effective leader within the ITW community speaks for itself. We are ...
Breaking Medicine News(10 mins):Health News:Pixel Film Studios Releases FCPX Transition TransFlip for FCPX 2Health News:The New Foundation AZ Renovates Residential Dorms for Youth in Crisis 2Health News:The New Foundation AZ Renovates Residential Dorms for Youth in Crisis 3Health News:HealthPostures and 247Ergo Partnership Strengthens America's Wellness 2Health News:HealthPostures and 247Ergo Partnership Strengthens America's Wellness 3Health News:SkinSmart Dermatology is First in Sarasota to Offer Kybella Treatments to Reduce Double Chin Fat 2Health News:SkinSmart Dermatology is First in Sarasota to Offer Kybella Treatments to Reduce Double Chin Fat 3Health News:Gina Powers Named Vice President & General Manager of ITW Dynatec 2Health News:Gina Powers Named Vice President & General Manager of ITW Dynatec 3
... ... fitness professionals as one of the most effective ways to burn calories and increasing cardiovascular ... works your core, as well as shaping your glute, legs, and stomach muscles like inline ... Chicago, IL (PRWEB) ...
... ... inaugural membership campaign, which will offer San Jose residents the opportunity to ... parks and trails. "The coming budget cuts could have a negative impact ... – and in some cases enhance – our parks and trails." ParkForce ...
... Understanding how health ... and Q&A session presented by Wiley Long, President of the HSA for America group of ... 21, 2010. ,Reserve a Free Phone Line for the Teleseminar at www.HSAforAmerica.com/teleseminar.htm ,Or call ... ...
... After ten years of ... and reflects on what sets his accredited surgery center apart from the rest. ... (PRWEB) May 17, 2010 -- There is ... cost cuts and short cuts. Dr. Delgado opened Marin Cosmetic Surgery Center with the vision of ...
... ORLEANS Patients with severe asthma who use an internet-supported ... were able to control their asthma with lower overall ... usual care, according to research from the Netherlands. ... it is important to adjust the daily dose of ...
... an NIH research network study provide new information on how ... first day of life and the most effective means to ... oxygen levels improve preterm infants, survival but increase the risk ... second was that a treatment typically used for adults with ...
Cached Medicine News:Health News:Fight Obesity with Fitness Entrepreneur's New Product That Makes Inline Skating Safer 2Health News:San Jose Parks Foundation Launches "ParkForce" Campaign to Protect and Preserve San Jose's Parks & Trails 2Health News:San Jose Parks Foundation Launches "ParkForce" Campaign to Protect and Preserve San Jose's Parks & Trails 3Health News:San Jose Parks Foundation Launches "ParkForce" Campaign to Protect and Preserve San Jose's Parks & Trails 4Health News:Wondering What Will Happen With Your Health Insurance in the Wake of Health Care Reform? 2Health News:Marin Cosmetic Surgery Center "The Center of Excellence" Celebrating It's Upcoming Tenth Year Anniversary With Miguel A. Delgado, Jr., M.D. 2Health News:Marin Cosmetic Surgery Center "The Center of Excellence" Celebrating It's Upcoming Tenth Year Anniversary With Miguel A. Delgado, Jr., M.D. 3Health News:Internet monitoring strategy for severe asthma patients shown to be effective 2Health News:Internet monitoring strategy for severe asthma patients shown to be effective 3Health News:Higher oxygen levels improve preterm survival, increase risk for eye condition 2Health News:Higher oxygen levels improve preterm survival, increase risk for eye condition 3Health News:Higher oxygen levels improve preterm survival, increase risk for eye condition 4Health News:Higher oxygen levels improve preterm survival, increase risk for eye condition 5
(Date:7/28/2015)... 2015 On the afternoon of August 11, ... CPI International, Inc. (CPI), plans to file its Form ... with the Securities and Exchange Commission and to issue ...  At 11 a.m. (EDT) on Wednesday, August 12, 2015, ... with this release that will be Web cast simultaneously ...
(Date:7/28/2015)... -- A German Diabetes Center clinical study found that ... enriches human gut microbiota and modifies gut production of ... daily administration of Nutraceutix,s L. reuteri strain ... tract ® delivery technology that protects live ... to the intestinal tract. The randomized, double-blind, ...
(Date:7/28/2015)... The Physician-Patient Alliance for Health & Safety ... Surviving Your Hospital Stay ." "Help us ... of these patients went home from hospital," said ... referring to the patient stories presented at ... Promote Continuous Monitoring of Patients on Opioids (shown ...
Breaking Medicine Technology:CPI International To Announce Third Quarter 2015 Financial Results 2Nutraceutix's L. reuteri Probiotic Clinically Proven to Modulate Gut Insulin Metabolism 2Surviving Your Hospital Stay: Physician-Patient Alliance for Health & Safety Launches Fundraising for Patient Safety 2
The Array 360 CEAL streamlines processes with computer enhancements and optimizes productivity by offering an exclusive design for aliquot samples....
ELISA kit for detection of Rheumatoid Factor....
EXTEND is an absorbable synthetic punctal implant that provides occlusion up to three months. It is packaged 20 implants per box in sizes of .0.3mm, 0.4mm, 0.5mm. A variety pack in also available w...
... now can have accurate patient information and secure ... Keep track of patient schedules, manage daily workflow ... Pocket PC handheld device. PhysAssist IQ is a ... that does not require physicians to change the ...
Medicine Products: