enigl at aol.com
Sun Jan 18 21:54:26 EST 1998
In article <69jp0h$bhv$1 at nntp.Stanford.EDU>, "Barry Lifland"
<blifland at leland.stanford.edu> writes:
> Biolog has chosen not to enter the clinical market.
According to the Biolog representative at the InterPhex show, they did enter
the Clinical market and she was trying to sell the Biolog to two hospital Med
Techs. at the time I was speaking to her. I don't know if BIOLOG is an FDA
_approved_ medical device (required for clinical use) or not. If not,
hospitals can't legally use the system--FDA must approve it as a "medical
device"-- even if the system is validated for cGMP.
Davin C. Enigl, MEAS. Microbiology Consultant for Foods, Cosmetics,
Pharmaceuticals and Biotechnology. FDA validation protocols, water system,
autoclave, facility start-up. Author: _Preservative-Free and Self-Preserving
Cosmetics and Drugs_ Marcel Dekker.
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