[Histonet] RE: FDA Disclaimer

Morken, Timothy Timothy.Morken <@t> ucsfmedctr.org
Wed Sep 24 13:24:11 CDT 2014

Karla, the thing is, they may be called "IVD" under FDA nomenclature,  but they are not all FDA "approved." Class I exempt antibodies  (the vast majority) don't need FDA "approval" because they are ancillary tests used in conjunction with other tests to arrive at a Dx.  Only stand-alone tests like ER, Pr, Her2 and EGFR are in Class II and require FDA approval.

An FDA certified company can list any antibody (except the stand alones) as IVD Class I simply by submitting a list to FDA. The company must have FDA approved quality controls in place and follow a slew of regulations to do so, but it is simply a paperwork exercise after that. 

So, the disclaimer you mention says that the antibody in question is not FDA approved, but is not required to be FDA approved. The CAP and ASCP suggested this disclaimer so that customers would be made to understand that although the tests are not under FDA approval it does not mean they are not valid tests. 

Tim Morken
Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
UC San Francisco Medical Center
San Francisco, CA

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-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Arrington, Karla A
Sent: Wednesday, September 24, 2014 10:44 AM
To: 'histonet <@t> lists.utsouthwestern.edu'
Subject: [Histonet] FDA Disclaimer

To All:

We are starting up IHC at the lab and I have a question about disclaimer.

If we are using all FDA approved antibodies, do we need the FDA Disclaimer on our pathology reports?
And if so, what should it say?

Karla Arrington =)

Karla Arrington, HT(ASCP), HIT(AHIMA)
Lead Histology Technician
ANMC Pathology
kaarrington <@t> anthc.org

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