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Legal and Regulatory Aspects of Face Donation and Transplantation

  • Alexandra K. Glazier
Chapter

Abstract

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.

Keywords

Composite Graft Facial Graft Face Transplantation Jurisdictional Authority Anatomical Gift 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Abbreviations

CMS

Centers for Medicare Services

FDA

Food and Drug Administration

HHS

Health and Human Services

HRSA

Health Resources Services Administration

IRB

Institutional Review Board

NOTA

National Organ Transplant Act

OHRP

Office of Human Research Protections

OPO

Organ Procurement Organization

OPTN

Organ Procurement and Transplantation Network

UAGA

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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