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:7/22/2017)... CANADA (PRWEB) , ... July 22, 2017 , ... ... offer patients with irreparable rotator cuff repairs the opportunity to return to sports ... the American Orthopaedic Society for Sports Medicine’s Annual Meeting in Toronto, ...
(Date:7/21/2017)... ... ... The Ellis Agency, an eastern Georgie provider of insurance management and financial ... event with the goal of bringing in support for epilepsy patients in the greater ... recently launched a charity campaign of her own by donating her birthday to the ...
(Date:7/21/2017)... Long Grove, Ill. (PRWEB) , ... July 21, 2017 , ... ... Air & Fabric Liquid eco-friendly odor-control solution for colleges and universities at the ... to safely and effectively eliminate severe cannabis and tobacco smoke odors without the use ...
(Date:7/21/2017)... (PRWEB) , ... July 21, 2017 , ... The Margarian ... falsely advertising the contents of its ginger ale for allegedly containing no ginger. Dr. ... Dr. Pepper Snapple Group, Inc., plaintiff Gegham Margaryan alleges Canada Dry Ginger Ale claims ...
(Date:7/21/2017)... ... July 21, 2017 , ... “Kids aren't born knowing ... tie their shoes,” says Suzanne Tucker, Founder of St. Louis-based positive education company Generation ... launches on Kickstarter on Monday, July 21st. , The kit uses colorful, engaging ...
Breaking Medicine News(10 mins):
(Date:7/10/2017)... N.C. , July 10, 2017 Locus ... Convertible Note to support the development of CRISPR-Cas3 antimicrobial ... Holdings Limited, a leading Chinese Internet services provider, and ... will advance multiple infectious disease product programs targeting antibiotic ... Founded by Dr. Rodolphe Barrangou ...
(Date:7/5/2017)... -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ... pharmaceutical company focused on the development of oral drug delivery ... Israel Securities Authority to dual-list its common stock on the ... trading on the TASE on July 12, 2017 under the ... Company, it is expected that Oramed will be included in ...
(Date:7/1/2017)... , June 30, 2017 Zimmer Biomet Holdings, Inc. ... and earnings conference call will be broadcast live over the ... Time.  A news release detailing the quarterly results will be ... the conference call. The live audio webcast can ... http://investor.zimmerbiomet.com . It will be archived for replay following the ...
Breaking Medicine Technology: