Guidance Document - American Association of Tissue Banks

A29. Any claim is required to be fully verified or validated and justified with data.Q30. How will labeling claims be distinguished between for reconstruction, repair,replacement or supplementation, and therapeutic or clinical outcome? Theterm “repair” implies an outcome or result of clinical use. In this context, itis difficult to conceive of a therapeutic or outcome-based claim that is notdirectly related to repair. As an example, if a graft is labeled as being “nonimmunogenic”,the implication is that the repair process will be lesshindered by immune response in the patient.A30. Any claim is required to be fully verified or validated and justified with data. Theestablishment must decide how to best demonstrate through fully verifiable testing.Q31. It’s understood that the distinct identifier code must appear on an individualallograft’s immediate label of the package it is packaged within, but is it alsoexpected that the distinct identifier code appear on the generic packageinsert information that accompanies the distributed allograft ? This packageinsert may also include information that serves as the “summary of records.”A31. No, there is not an expectation that the distinct identifier code appear on allpackage inserts or specifically, on the summary of records. It’s understood thatthe requirements of the summary of records content can be fulfilled by using awell-crafted description used in a generic fashion for that tissue type. The ability tosuccessfully perform tracking of tissues (the intent of 1271.290) is notcompromised if the distinct identifier does not also appear on the allograft packageinsert. The package insert information is distributed with the allograft but whenreceived by the consignee, what they do with this type of information is at theirdiscretion and not within the scope of federal regulations. The ability of the bank toprovide successful tracking to the consignee is not compromised by not includingthe distinct identifier on the package inserts sent with distributed allografts. Also,the components of the summary of records as described in 1271.55(b) do notinclude the distinct identification code and the intent of 1271.55(a) is met with thedistinct identification code clearly indicated on the allograft’s immediate label.Page 32 of 44