Thursday, January 26, 2012 10:03:53 AM
the US FDA ensures both the safety and the efficacy of new devices
other countries are just concerned about safety. So you can scam anyone around the world saying your device cures anything so long as it does no harm. US FDA approval means it actally does what it claims.
the rest of the mumbo jumbo is all bout different processes IMHO had AW known the de Novo would take this long he would have done different approach to get Rx for more treatments and even Allay separate from Actiptch. Now everything is I believe lumped together and due for decision "in a few weeks".
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