Legal and Regulatory Aspects of Face Donation and Transplantation

  • Alexandra K. Glazier


Face transplantation, like many new experimental procedures, emerged into the field without clear regulatory oversight. New surgical techniques, squarely within the “practice of medicine,” are generally not regulated in the USA unless the surgical procedure involves a device for which FDA approval is required. Transplantation of organs and/or tissues, however, is one of the most highly regulated fields within medicine. Multiple federal agencies, national standards, and state laws and regulations provide a tight system of oversight for the donation and transplantation of organs and tissues. This chapter examines how face transplantation may be adopted into this framework based on previous experience with solid organs in the USA.


Composite Graft Facial Graft Face Transplantation Jurisdictional Authority Anatomical Gift 
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Centers for Medicare Services


Food and Drug Administration


Health and Human Services


Health Resources Services Administration


Institutional Review Board


National Organ Transplant Act


Office of Human Research Protections


Organ Procurement Organization


Organ Procurement and Transplantation Network


Uniform Anatomical Gift Act


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Copyright information

© Springer London 2011

Authors and Affiliations

  1. 1.New England Organ Bank, IncWalthamUSA

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