Rob Packard My expertise is not IVD labeling, but the person indicated as the contact for that guidance is Elizabeth Mansfield. Her email is: [email protected] She is extremely helpful to industry and you are likely to get a response to clarify any questions you have. I sent her your question without revealing the source. I will post another comment when I receive a reply. In the meantime, hopefully others with IVD labeling experience will contribute additional comments. I suspect there is some variation between companies, because verification and validation phases are not always organized in the same way at each company and may be product-specific.

Luisa Mella Robert, thanks for your comment and interest in this topic. Since actually we also sell medical devices, not only IVDs, how would you label in US market a medical device in verification and then validation phase?
Are there any particular restrictions, such as for example manufacturer symbol or others that need to be on the label?
Thanks for asking FDA, we will for sure wait for their reply, and also the comments of any group members with knowledge on this topic.
Thanks all again!

Rob Packard IVD products are somewhat unique, because they represent no risk to humans since they are used in vitro. Non-IVD medical devices are used on humans, and therefore we are not allowed to do any verification except on a cadaver. In the case of cadaver studies we typically label the product as "not for human use." If you are doing an animal model for your validation study, then you could label product as "for animal use only" or "not for human use." There is no formal guidance for cadaver or animal study labeling. Once you leave the animal and cadaver realm, then you have to follow good clinical practices (GCPs) or you need IDE approval for studies of significant patient risk. In both cases, the labeling requirements are clearly defined by the FDA as "for investigational use only" and the labeling is reviewed and approved prior to conducting the study--either by the FDA and the IRB or at least the IRB. In fact, the entire investigative brochure will be reviewed and approved.

Luisa Mella Dear Robert, did you get any answer from FDA maybe? thanks a lot! Luisa

John Beasley, MSc, RAC (US) "IVD devices represent no harm to humans" is clearly misstated.

When I first read the post, I recalled a scene from the television series, The X-Files, where The Smoking Man tells Deep Throat "you've killed more people with your lies than I have with my gun". This is comparable to IVD results indicating false positives or false negatives for presence of cancer, illicit drugs, pregnancy, virus, etc. Harm is done.