Vascularized composite allograft

Vascularized composite allograft 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; and
(9) Susceptible to allograft rejection, generally requiring immunosuppression that may increase infectious disease risk to the recipient.


42 CFR § 121.2

Scoping language

As used in this part -

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