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 <>
Content-Type:text/plain; charset="us-ascii"

When I tried to open the file (CDRH), I received a message "File Not Found"
Is this the correct link?

	From:  Peter Takes[]
	Sent:  Thursday, October 01, 1998 8:04 AM
	To:  Laura Bliven;
	Subject:  Re: IHC non-FDA Approved Tests


	A great deal of information on IHC-FDA-related issues can be found
	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
	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
	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
	relating to non-FDA approved IHC reporting and testing.  Is there a
	site one can access for this information?  I have to participate in
	meeting about this and would like to make it sweet and short.
	> Thanks in advance.
	> Laura

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