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.
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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
References
Uniform Anatomical Gift Act (2006) at www.nccusl.org.
See e.g. Cantebury v. Spence, 464 F.2d 772 (D.C. 1972).
42 CFR §482.102(a).
45 CFR §46.116.
United Network for Organ Sharing. www.unos.org.
42 U.S.C. §274 et seq.; 42 C.F.R. Part 121.
42 U.S.C. §274 et seq.
Medicare and Medicaid programs: Conditions for coverage for organ procurement organizations. Fed Regist. 2006;71(104):30982-31054.
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.
21 U.S.C. 301 et seq.; 42 U.S.C. §201 et seq.
21 C.F.R. Parts 16, 1270 and 1271.
21 C.F.R. §1271(3)(d)(1).
21 U.S.C. §301 et seq (The Food Drug and Cosmetic Act); 42 U.S.C. §201 et seq. (Public Health Services Act).
45 C.F.R. Part 46.
45 C.F.R. 46.102(f)(defining “human subject” as a “living individual”).
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.
HRSA. Organ procurement and transplantation network [notice]. Fed Regist. 2008;73(42):11429. Id. at 11422.
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© 2011 Springer London
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Glazier, A.K. (2011). Legal and Regulatory Aspects of Face Donation and Transplantation. In: Siemionow, M. (eds) The Know-How of Face Transplantation. Springer, London. https://doi.org/10.1007/978-0-85729-253-7_25
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DOI: https://doi.org/10.1007/978-0-85729-253-7_25
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