Regulatory Face-Off: What Agency Should Oversee Face Transplants?

The world of organ and tissue transplantation currently exists within a striking regulatory divide. This is based in part because organs and tissues donated and recovered for transplantation have significantly different clinical pathways. One fundamental difference is that donated organs are transplanted almost immediately after recovery whereas donated tissues are quarantined and processed before use. Also, the medical necessity for biological compatibility combined with the fact that there over 98 000 Americans awaiting organ transplantation, makes fair and appropriate allocation a primary regulatory concern for organs (1).