Tuesday, November 16, 2010 3:48:31 PM
It is Important to investors because it is the easiest for us to overcome with a high powered Law team.
'mr_sano' wrote,
"...If the predicate device is not configured in the same manner with like controls then it has to be NSE...."
Here is FDA Guidance on 510K note this excerpt:
A device is substantially equivalent if, in comparison to a predicate it:
* has the same intended use as the predicate; and
* has the same technological characteristics as the predicate;
or
* has the same intended use as the predicate; and
* has different technological characteristics and the information submitted to FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the legally marketed device.
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