RE: IHC non-FDA Approved Tests
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From: | "Gamble,Marilyn S" <Marilyn.S.Gamble@kp.ORG> (by way of histonet) |
To: | histonet <histonet@magicnet.net> |
Reply-To: | |
Content-Type: | text/plain; charset="us-ascii" |
Peter,
When I tried to open the file (CDRH), I received a message "File Not Found"
Is this the correct link?
Marilyn
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From: Peter Takes[SMTP:ptakes@stereotaxis.wustl.edu]
Sent: Thursday, October 01, 1998 8:04 AM
To: Laura Bliven; histonet@Pathology.swmed.edu
Subject: Re: IHC non-FDA Approved Tests
Laura:
A great deal of information on IHC-FDA-related issues can be found
at
JCIM's web site: http://www.jcim.org. 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
Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Stereotaxis, Inc.
Ph. 1-314-615-6964; Pager: 841-9351
ptakes@stereotaxis.wustl.edu
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> From: Laura Bliven <blivenl@dgabby.mfldclin.edu>
> To: histonet@pathology.swmed.edu
> 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
> blivenl@mfldclin.edu
>
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