[Histonet] RE: FDA Disclaimer

[Morken, Timothy]

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

CONFIDENTIALITY NOTICE: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, proprietary, and/or privileged information protected by law. If you are not the intended recipient, you may not use, copy, or distribute this email message or its attachments. If you believe you have received this email message in error, please contact the sender by reply email and destroy all copies of the original message.


-----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
907-729-1810
kaarrington <@t> anthc.org

_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet