Table 1.

Defining criteria for a vascularized composite allograft (VCA)

VCA means a body part:
1. That is vascularized and requires blood flow by surgical connection of blood vessels to function after transplantation
2. Containing multiple tissue types
3. Recovered from a human donor as an anatomical/structural unit
4. Transplanted into a human recipient as an anatomical/structural unit
5. Minimally manipulated (i.e., processing that does not alter the original relevant characteristics of the organ relating to the organ’s utility for reconstruction, repair, or replacement)
6. For homologous use (the replacement or supplementation of a recipient’s organ with an organ that performs the same basic function or functions in the recipient as in the donor)
7. Not combined with another article such as a device
8. Susceptible to ischemia and, therefore, only stored temporarily and not cryopreserved
9. Susceptible to allograft rejection, generally requiring immunosuppression that may increase infectious disease risk to the recipienta

Adapted from http://federal.eregulations.us/fr/notice/7/3/2013/2013-15731 [13].

^a In exceptional cases (identical twins or sharing of highly concordant histocompatibility matching markers), the recipient might not require any immunosuppression.