Friday, October 15, 2010
FDA to rescind 510(k) clearance
The FDA is taking steps to rescind the 510(k) clearance of a knee implant because they made errors in the original clearance process. Now we finally know they really are bureaucrats, even though they present themselves as being "scientific". Apparently procedure takes precedence over science. This device has so far been used in over 300 cases over a period of 10 years without any complaints. Read this article in the WSJ and don't forget to go to the Comments tab.
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