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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."

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SOURCE Endotec Inc.
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