<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Nightwriter</b></i>
Save Ferris,
. BTW, the FDA DOES approve medical devices:
The DeVilbiss Pulmo Aide® compressor nebulizer has been providing effective aerosol treatments for more than thirty years. The DeVilbiss Pulmo Aide® compressor nebulizer is the only compressor approved for use with TOBI (tobramycin solution for inhalation).
</end quote></div>
Ugh do you know why that is? Because when TOBI was brought to the market, the clinical trials done with TOBI were with DeVilbiss.
DeVilbiss was already FDA cleared and when TOBI was used in clinical trials, that was the compressor they chose.
It wasn't the other way around.
For example, aztreonam is being studied in clinical trials. The compressor they chose was the eFlow. This isn't to approve the eFlow with aztreonam, it's to approve aztreonam with a certain compressor.
So, as I've said 3 times now, medical devices don't go through trials with drugs. Drugs go through trials for use with certain devices.
The eFLow is cleared to be used in the US with any medication. Just like when the DeVilbiss received FDA clearance, it was cleared to be used with any medication.
What you quoted was bringing a drug to market, not bringing a device to market. They're very different processees and you're not understanding the differences.
Do yourself a favor and call the FDA, call PARI, call Novartis, call anyone to help explain this to you because clearly you're not understanding how this process works.
<div class="FTQUOTE"><begin quote>
However, I am working, and alas do not have the time, to debate all your apples and oranges debates.
</end quote></div>
Well, your statements are inaccurate and I will keep pointing out the inaccuracies. Your facts are blatantly incorrect, and it's much bigger than just an apples to oranges debate. The FDA will tell you the same. Call them.
As I have said here and as I say on my blog, you can get the eFlow for 100% free of charge if you use tobramcyin or colistin nebulized.
And why is the eFlow accessible in the US for these meds? Simple. Because in 2004, the FDA gave clearance for the device for use with any medication. Which is why no one's licenses are being pulled, docs are going to jail, and why it's legal to sell the device in the US.
Insurance companies are paying for it. Just because yours aren't, doesn't mean others aren't.
And yes, there are human studies with the eFlow.