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- See also: Biomedical material and Implant (medicine)
Biomedical tissue is biological tissue used for organ transplantation. There is a large demand for these human tissue products and the supply can not keep up with this demand. Each country sets its own framework for ensuring the safety of human tissue products. In the US this is monitored by the Food and Drug Administration (FDA).
Such tissues and organs may be referred to as: implant tissue, allograft, xenograft, skin graft tissue, human transplant tissue, implant bone.
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Regulation in the United Kingdom
The regulation of human transplantation in the United Kingdom is set out in the Human Tissue Act 2004 and managed by the Human Tissue Authority.1
Regulation in the United States
The Code of Federal Regulations sets out the following topics:2
- Donor Screening and Testing: the determination of donor suitability for human tissue intended for transplantation.
- Procedures and Records: the written procedures and records that must be kept
- Inspection of Tissue Establishments: including issues of the import of tissues from abroad as well as the retention, recall, and destruction of human tissue.
Notable regulation cases
- Biomedical Tissue Services, Inc. is at the heart of an investigation by the Food and Drug Administration. [1]
External links
Footnotes
- ^ Human Tissue Authority. "Remit".
- ^ Food and Drug Administration (2003). "Part 1270: 'Human Tissue Intended for Transplantation'". Title 21--Food and Drugs. Code of Federal Regulations.
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- This page was last modified on 22 March 2008, at 20:26.
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