Navigation Links
FDA Gets Knocked Out in Endotec, Inc. Ruling
Date:8/18/2008

e medical devices exempt from FDA regulation.

Eight years after his ankle replacement surgery, Vincent has no restrictions. He exercises regularly three-days a week, rides a stationary bike, lifts weights, hikes over mountain roads, traverses trout streams, and rides his 15-speed bike five to 10 miles several days each week.

"I have my life back," said Vincent. "I was a college athlete and high-school basketball coach, and I was extremely active. Following this surgery, I no longer have sharp or stabbing pains. I am continuing to improve and can get around better than I have in years."

"This is a huge victory because it allows me to do what I've been doing for 30 years which is replacing ankles in patients who need it," said Dr. Buechel. "The FDA is out of touch with reality. When they take common sense and distort it and try to limit it, they overstep their bounds and become bureaucrats -- ignoring the science underlying their regulatory authority."

Judge Sharp criticized the FDA in his decision, saying that the agency's "stringent regulations and strict interpretation of procedural requirements are resulting in technological innovation being stymied, rather than advanced." He noted that the FDA never alleged that Endotec's devices harmed any patients or were dangerous. Judge Sharp twice took the FDA to task for "stymieing progress and technological advancement." Moreover, he rebuked the FDA's expert witness on custom devices, associate director of regulatory guidance, Casper Uldriks, for defining a custom device in a way that was "so narrow as to make the definition useless."

"For the first time in history, the FDA has brought a suit on custom medical devices and lost," said Michael Pappas, Ph.D, CEO, Endotec, Inc. "This sends a powerful message to the industry not to fear the FDA, or to be intimidated by their tactics. Power not only breeds corruption, it also breeds arrogance, and arrogance breeds stupidity."

According t
'/>"/>

SOURCE Endotec Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Arbitration Panel Issues Ruling in Distribution Dispute
2. Barr Announces Favorable Ruling in Mirapex(R) Patent Challenge
3. Eisai is Granted Favorable Preliminary Injunction Ruling in Aricept(R) Patent Infringement Lawsuit Against Teva Pharmaceuticals
4. Barr Announces Favorable Ruling in Yasmin(R) Patent Challenge
5. AstraZeneca Response to February 21, 2008 Ruling In Re: Alabama Medicaid Pharmaceutical AWP Litigation - cv2005-219 - Circuit Court of Montgomery, Alabama
6. Sigma-Aldrich and Oxford BioMedica Win Key Ruling in Open Biosystems Patent Infringement Dispute
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... Dec. 22, 2014  ( www.competitivehealth.com ) — Competitive ... medical bill review and advocacy service, has signed an ... WellCard Savings discount health services marketplace. 63% ... more than they expected to pay. As part of ... costs, WellCard Savings is pleased to offer medical bill ...
(Date:12/22/2014)... 22, 2014 Fertility Associates of Memphis ... Bank USA , a network of more than 20 ... partnership, patients have fast access to a national pool ... IVF . Fertility Associates of Memphis is the only ... treatment option. , Dr. William Kutteh , director ...
(Date:12/19/2014)... BioPlus Specialty Pharmacy (BioPlus), one ... of Nick Maroulis, Pharm.D. to the newly created position ... In this position, Dr. Maroulis will continue to manage ... of our multi-site pharmacies as the company expands. Dr. ... that time he has served in many different capacities ...
(Date:12/19/2014)... Dec. 19, 2014 Bina Technologies, Inc. (Bina, ... that they have been acquired by Roche (SIX: RO, ... privately held company that provides a big data platform ... (NGS) data for the academic and translational research markets. ... and will continue to focus on development of their ...
Breaking Biology Technology:WellCard Savings Announces CoPatient Medical Bill Review Service for Members 2Fertility Associates of Memphis Announces Partnership with Donor Egg Bank USA 2Fertility Associates of Memphis Announces Partnership with Donor Egg Bank USA 3BioPlus Specialty Pharmacy Promotes Dr. Nick Maroulis to Vice President of Specialty Pharmacy Services 2Bina Technologies is acquired by Roche. 2Bina Technologies is acquired by Roche. 3
... AltheaDx, Inc . today announced the ... molecular pathology lab for application in biomarker discovery and ... both monitoring known and discovering new complex genetic changes ... addition of NGS greatly expands our OncoScore™ initiative and ...
... June 27, 2011 MedeAnalytics, a leading provider ... launch of its Patient Access Resource Center. Created ... end of the revenue cycle, the resource center ... and industry trends, as well as best-practice tools ...
... LA JOLLA, Calif., June 24, 2011 Cebix Incorporated ... of C-peptide, Ersatta™ (CBX129801), demonstrated a half-life ... native C-peptide. Ersatta halted the impairment in nerve conduction ... signals travel through the nerves, in an animal model ...
Cached Biology Technology:AltheaDx Incorporates Next-Generation Sequencing Into Its Clinical Testing Pipeline. 2AltheaDx Incorporates Next-Generation Sequencing Into Its Clinical Testing Pipeline. 3Cebix's Long-Acting C-Peptide Ersatta™ has Potential in Multiple Chronic Complications of Diabetes 2Cebix's Long-Acting C-Peptide Ersatta™ has Potential in Multiple Chronic Complications of Diabetes 3
(Date:12/17/2014)... 2014 Research and Markets ( ... "Samsung Galaxy S5 - Home Button Synaptics ... offering. http://photos.prnewswire.com/prnh/20130307/600769 ... technology than the iPhone 5S, Samsung introduces for ... product. The Galaxy S5 home button ...
(Date:12/17/2014)... Dec. 16, 2014 Research and Markets ... of the "Global Chemical Sensor Market 2015-2019" ... http://photos.prnewswire.com/prnh/20130307/600769 One major ... demand for medical sensors in biomedical applications. Chemical ... quick and correct diagnosis during surgical procedures. The ...
(Date:12/11/2014)... , Dec. 09, 2014 Research and ... ( http://www.researchandmarkets.com/research/9ql3kr/biometrics_market ) has ... in India 2015-2019" report to their offering. ... this market is the adoption of multimodal biometric ... characteristic of an individual for verification and identification ...
Breaking Biology News(10 mins):Samsung Galaxy S5 - Home Button Synaptics Fingerprint Sensor Technology Analysis 2Global Chemical Sensor Market 2015-2019: Key Vendors are Abbott Laboratories, Bayer, Hoffmann La-Roche, Johnson & Johnson, NGK Spark Plugs and Robert Bosch 2Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2
... Johns Hopkins Malaria Research Institute have developed a new method ... , an important but less studied spreader of human malaria. ... primary cause of malaria in humans in South America and ... genome of the An. albimanus mosquito has not ...
... 2013 Arthur Lander, a recognized leader in the emerging ... causes for some cancers and birth defects, has been named ... UC Irvine. The Bren Professors Endowment was established with ... to help UC Irvine attract and retain the nation,s foremost ...
... has been studying several hybrid nanomaterials, i.e. combinations of synthetic ... defend his doctoral thesis at the University of Helsinki in ... on the scale of a billionth of a metre, matter ... Neither is it always known what types of effects the ...
Cached Biology News:New method for researching understudied malaria-spreading mosquitoes 2Developmental biologist Arthur Lander named Donald Bren Professor 2Is nanosilver toxic? 2Is nanosilver toxic? 3
... protein A media yield highly purified ... to analysis of other immunoglobulin classes, ... purification. Protein A binds to the ... from mammalian species. This ready-to-use, bottled ...
... bis- (3-D-Gluconamidopropyl)deoxycholamide White solid. HYGROSCOPIC. ... CHAPSO. Has reduced electrostatic interactions that do ... DEAE-cellulose. Aggregation number: 8-16. Purity: ≥95% ... O. Aggregation number 8 - 16, CMC ...
Goat Anti-Horse IgG(T) Antibody, Unconjugated...
Goat polyclonal to STMN2 ( Abpromise for all tested applications). Antigen: Synthetic peptide: AKTAMAYKEK, corresponding to C terminal amino acids 2-11 of STMN2. Entrez Gene ID: 11075 Swi...
Biology Products: