Navigation Links
Supreme Court Hears Case on Federal Pre-emption of Safety Standards for Medical Technologies (Riegel v. Medtronic, Inc.)
Date:12/4/2007

FDA - Not Lawsuits - Should Determine Safety & Efficacy of Medical Technology

WASHINGTON, Dec. 4 /PRNewswire-USNewswire/ -- AdvaMed General Counsel Christopher White issued the following statement today regarding oral arguments presented before the U.S. Supreme Court on the matter of Riegel v. Medtronic, Inc.:

"As was made clear in today's arguments, the safety and efficacy of medical technologies are best determined by Food and Drug Administration (FDA) scientists -- not by lawsuits filed in courtrooms across the country. Allowing states to serve as secondary regulatory bodies would undermine the established science-based review process in place for medical devices and diagnostics and slow down patient access to these life-saving and live enhancing products.

"The comprehensive pre-market approval process at the FDA subjects medical devices to intense scrutiny at every stage of development and marketing -- from clinical studies to real-world clinical use. A state-law liability approach to assessing safety and effectiveness would undermine this approach to patient safety. It also would override the specific intent of the U.S. Congress that the FDA be responsible for the timely approval of safe and effective medical technologies.

"We are hopeful the Supreme Court will re-affirm the two previous lower court rulings in this case which made clear that the Medical Device Amendments (MDA) to the Federal Food Drug and Cosmetic Act (FDCA) expressly provide for FDA's ultimate regulatory authority in these matters."

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org.


'/>"/>
SOURCE AdvaMed
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Texas Supreme Court Rules Against Medicare HMOs in Hospital Reimbursement Fight
2. Filing for Reconsideration/Press Conference ACUNA v. TURKISH, Historic Informed Consent Abortion Case to the New Jersey Supreme Court
3. ALLs Judie Brown: Supreme Court is Wrong on Contraception Ruling
4. Autism Speaks Applauds Supreme Court Decision Upholding Families Right to Challenge IEPs Without First Trying Out School District Proposed Placement
5. California Veterinary Medical Association Reacts to Supreme Court Decision
6. Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtronic, Inc.
7. Claim Filed Against the Company and Nine Other Defendants in the Haifa Magistrates Court
8. First Circuit Court of Appeals Rules Against Philip Morris in Lights Class Action
9. Wyeth and Nycomed Announce Court Denial of Preliminary Injunction
10. Massachusetts State Court Hears Suit by Breastfeeding Mother on Medical Licensing Exam
11. Cristina Saralegui Joins Celebrities Including Matthew McConaughey, Courteney Cox and Mariska Hargitay to Raise Money for Breast Cancer Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... ... February 22, 2017 , ... ... with so many different solutions on the market, it is easy to start ... Texas Premier Locksmith offers a complimentary security consultation. , Home Security Hardware ...
(Date:2/22/2017)... ... February 22, 2017 , ... Apptricity® Corporation, a leading ... spend management, today announced that Keppel Corporation has selected Apptricity Travel and Expense ... , “We are excited to announce the partnership between Keppel and Apptricity for ...
(Date:2/21/2017)... Okla. (PRWEB) , ... February 21, 2017 , ... ... new Choctaw Nation Regional Medical Clinic in Durant, Oklahoma, on Feb. 21. , ... by clinic tours for community members, clinic employees, the construction team and tribal ...
(Date:2/21/2017)... CA (PRWEB) , ... February 21, 2017 , ... Doctors ... , CA, directed by Dr. Kendell Mendonca , to its growing network of ... compensation injuries including injuries stemming from car accidents such as whiplash, back pain, neck ...
(Date:2/21/2017)... Fort Worth, TX (PRWEB) , ... February 21, 2017 , ... ... planning assistance to communities in and around Tarrant County, is embarking on a six ... to research cures and treatments for cancer. , Cancer is one of the deadliest ...
Breaking Medicine News(10 mins):
(Date:2/22/2017)... SEATTLE , Feb. 22, 2017 ... translational development of novel immune modulating therapies, today ... the a9a10 nicotinic acetylcholine receptor (nAChR), demonstrates robust ... preclinical pain models. The study also establishes the ... the treatment of chronic pain. The findings were ...
(Date:2/22/2017)... , Feb. 22, 2017  Soligenix, Inc. ... Company), a late-stage biopharmaceutical company focused on developing ... there is an unmet medical need, announced today ... been granted a European patent for the treatment ... and methods of treatment of skin conditions, complements ...
(Date:2/21/2017)... -- IBM (NYSE: IBM ) Research has today announced new ... the eye,s retina. The Melbourne based ... recognize abnormalities in retina images, which could in the future ... of patients who may be at risk of eye diseases ... the developed world. The research began in ...
Breaking Medicine Technology: