Re: IHC non-FDA Approved Tests

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From:Peter Takes <> (by way of histonet)
To:histonet <>
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A great deal of information on IHC-FDA-related issues can be found at
JCIM's web site:  Under the new 'ASR' rule, if you are
using an antibody which has been labeled and sold as an 'ASR', there is new
MANDATORY disclaimer wording for surgical reports, mandatory by FDA and
subsequently HCFA (i.e., FDA can inspect your lab as well as HCFA).
Without going back to the rule, the exact wording escapes me at this time,
but you should be able to find info on JCIM's site.

Hope this is of some help.


Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Stereotaxis, Inc.
Ph. 1-314-615-6964; Pager: 841-9351

> From: Laura Bliven <>
> To:
> Subject: IHC non-FDA Approved Tests
> Date: Wednesday, September 30, 1998 3:36 PM
> Is anyone adding disclaimers to surgical reports pertaining to IHC
results, and if so how are they worded?
> Also, does anyone have information on the legal issues and implications
relating to non-FDA approved IHC reporting and testing.  Is there a web
site one can access for this information?  I have to participate in another
meeting about this and would like to make it sweet and short.
> Thanks in advance.
> Laura

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