[Histonet] Control block/slide regulation question

[Morken, Timothy]

Histonetters,  question came up about whether there are any regulations concerning where control blocks or slides are made. Specifically, whether a control TMA block must be made in a CLIA certified lab, as opposed to a research core facility.

I don't think there are any such regulations but would like to hear from anyone who has other knowledge. From what I know all that is required is that the TMA block/slides be validated per CLIA regulations within the CLIA -certified lab that is using them.

I've never known a vendor of controls to give any information concerning any type of FDA regulatory designation (IVD) either. So are they regulated at all? (maybe I should not even ask at the risk of giving them some bright ideas!?).

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

415.514-6042  (office)
tim.morken <@t> ucsfmedctr.org<mailto:tim.morken <@t> ucsfmedctr.org>

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.