FDA/IVD/CAP/???

From: Marc Langweiler (Marc.Langweiler@Dartmouth.EDU)
Date: Tue Dec 26 1995 - 13:04:21 EST

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Season's Greetings,

I'm hoping that someone from the clinical realm (USA), including any vendors,
might comment on the story in the December issue of CAP Today, entitled "Final
blueprint for unapproved reagents".

After reading the it, I'm not at all clear as to what is "new", based on the
recent meeting on IVD regulation that was discussed in the article.

I'd like to know if, and how, it will impact the "end users" in clinical labs.

Thanks in advance,

Marc Langweiler
marcl@dartmouth.edu   

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