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Enigl enigl at aol.com
Sun Jan 18 21:54:27 EST 1998


In article <69jp0h$bhv$1 at nntp.Stanford.EDU>, "Barry Lifland"
<blifland at leland.stanford.edu> writes:

>For
industrial use, FDA does not "approve" products. It is up to the user
>to
validate instrumentation and reagents. 

To clearify my statement:  The FDA has not "approved" the validation protocols
performed by any pharmaceutical companies (yet). . .  That is, they are still
at the FD-483 stage--i.e., non-compliance.   So, I guess you could say not able
to be used, even if FDA does not by som edefinitions "approve" nor "disapprove"
the use--expect validations.  However, the FDA HAS stated the ID systems are
"medical devices" subject to FDA "approval."

So, maybe "FDA approval"  really _is_ correct.  Medical device approval goes
WAY beyond "simple" validation "approval."


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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