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oddone33320

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oddone33320

Re: whirlybird post# 2766

Thursday, 09/13/2012 6:05:34 PM

Thursday, September 13, 2012 6:05:34 PM

Post# of 18483
From what I understand, the barriers to market for devices are far fewer than with pharmaceuticals. With that said I don't know how many trials you have to have to get to market but I am under the impression that the main thing you have to prove is that your device is safe which we already know it is. Effectiveness is secondary to that and we already know it is effective too. If they replicate their overseas studies in the USA then I don't think they'll have much of a problem getting approval.


Here are some links regarding an actual 510k approval time from submission to approval..Don't think it includes the study time?

http://meddevice.blogspot.com/2008/12/510k-approval-timeline.html

http://elsmar.com/Forums/showthread.php?t=33363
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