Marilyn:

I had the same problem.  I am copying Steve Tillson & Helene Paxton from
the JCIM Board on this memo so they are aware of the problem.

Instead of clicking on "CDRH", just click on "Bulletin Board" and the
information is there.

Peter


----------
> From: Gamble,Marilyn S <Marilyn.S.Gamble@kp.ORG>
> To: Laura Bliven <blivenl@dgabby.mfldclin.edu>;
histonet@Pathology.swmed.edu; 'Peter Takes' <ptakes@stereotaxis.wustl.edu>
> Subject: RE: IHC non-FDA Approved Tests
> Date: Thursday, October 01, 1998 10:56 AM
>
> Peter,
> When I tried to open the file (CDRH), I received a message "File Not
Found"
> Is this the correct link?
> Marilyn
>
> 	----------
> 	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
>
> 	----------
> 	> 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
> 	>
>