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Re: [IPp] Paradigm waterproofness

In a message dated 7/12/02 8:17:53 AM Central Daylight Time, 
email @ redacted writes:

> Someone can correct me on this if I am wrong but my understanding is that
> the FDA does no testing at all. All testing is done by the manufacturer or
> by subcontractors hired by the manufacturer. The FDA only reviews  the
> protocols, results and conclusions reported by the manufacturer.
> Pat
> ----------------------------------------------------------
> for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
> he

I am sure you are right....did any independent entity review the 
results.....my question if, of course, how do you get FDA approval and then 
change the perameters involved in the approval and not make changes in the 
pump.....this change is dramatic...had they not finished their testing before 
FDA approval? I am wondering what basis they are using for the change....hope 
I am making sense...sleep deprivation here....
Beverly, Mom to Mary, 8, dx'd 9/97, pumping, and Nick, who is now ten!
<A HREF="http://www.parsonwhitestudios.com/">http://www.parsonwhitestudios.com/</A> 
for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
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