Legal and Regulatory Aspects of Face Donation and Transplantation



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 
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.



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


  1. 1.
    Uniform Anatomical Gift Act (2006) at
  2. 2.
    See e.g. Cantebury v. Spence, 464 F.2d 772 (D.C. 1972).Google Scholar
  3. 3.
    42 CFR §482.102(a).Google Scholar
  4. 4.
    45 CFR §46.116.Google Scholar
  5. 5.
    United Network for Organ Sharing.
  6. 6.
    42 U.S.C. §274 et seq.; 42 C.F.R. Part 121.Google Scholar
  7. 7.
    42 U.S.C. §274 et seq.Google Scholar
  8. 8.
    Medicare and Medicaid programs: Conditions for coverage for organ procurement organizations. Fed Regist. 2006;71(104):30982-31054.Google Scholar
  9. 9.
    Medicare program; hospital conditions of participation; requirements for approval and re-approval of transplant centers to perform organ transplants; final rule. Fed Regist. 2007;72(61):15198-15280.Google Scholar
  10. 10.
    21 U.S.C. 301 et seq.; 42 U.S.C. §201 et seq.Google Scholar
  11. 11.
    21 C.F.R. Parts 16, 1270 and 1271.Google Scholar
  12. 12.
    21 C.F.R. §1271(3)(d)(1).Google Scholar
  13. 13.
    21 U.S.C. §301 et seq (The Food Drug and Cosmetic Act); 42 U.S.C. §201 et seq. (Public Health Services Act).Google Scholar
  14. 14.
    45 C.F.R. Part 46.Google Scholar
  15. 15.
    45 C.F.R. 46.102(f)(defining “human subject” as a “living individual”).Google Scholar
  16. 16.
    Cronin D, Millis M, Siegler M. Transplantation of liver grafts from living donors into adults: too much, too soon. N Engl J Med. 2001;344(21):1633-1638.PubMedCrossRefGoogle Scholar
  17. 17.
    HRSA. Organ procurement and transplantation network [notice]. Fed Regist. 2008;73(42):11429. Id. at 11422.Google Scholar

Copyright information

© Springer London 2011

Authors and Affiliations

  1. 1.New England Organ Bank, IncWalthamUSA

Personalised recommendations