FDA Review Criteria for Portable BG systems


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Posted by Ellen on March 02, 1999 at 19:44:39:

This is an interesting and LONG document (to me anyway). Notice how many times they blame the user for the innaccuracy of the meter...

Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro
Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase
Methodology

...Despite some problems with blood glucose monitors, a Consensus Panel of
physicians, educators, and laboratorians has recommended
blood glucose monitoring (BGMg) testing for insulin-treated .
The Panel, sponsored by the American Association, FDA, NIH,
and CDC, stated that most of the problems with current monitoring
systems involve the user and not the system itself.2 Thus, emphasis
should be placed on educating users and following up on their
performance........



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