Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003.
- United States. Congress. Senate. Committee on Governmental Affairs
- Date:
- 2003
Licence: Public Domain Mark
Credit: Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003. Source: Wellcome Collection.
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![and other serious conditions. Cells and tissues can also be used in combination with drugs or devices, and to deliver genes for gene therapies. Many cellular and tissue products are regulated by FDA as biological products under both the licensing provisions of the Public Health Service (PHS) Act and the Federal Food, Drug, and Cosmetic (FD&C) Act. Several categories of human tissue used for transplantation are regulated as medical devices under the 1976 Medical Devices Amendments, including heart valves, dura mater (the brain covering) and some demineralized bone products. Most human tissues for transplantation, as defined in Title 21, of the Code of Federal Regulations (CFR) Part 1270, are regulated under the Agency’s authority to prevent the transmission of communicable disease, section 361 of the PHS Act. FDA has three primary goals with respect to human tissues: (1) to prevent the spread of communicable diseases; (2) to ensure that safety and efficacy is demonstrated for cellular and tissue-based products that are also drug, biological, and medica] device products; and (3) to help enhance public confidence in these products so that, where appropniate, they can fulfill their great potential for saving and improving me We seek to accomplish these goals in a manner that will not discourage the development of new products. With the increased use of human tissue has come a heightened need to ensure greater tissue safety and minimize the potential risks. Developments in the 1980s and 1990s prompted FDA to examine its approach to tissue safety. Several incidents illustrate the nsks of infectious disease transmission when adequate precautions are not taken. During the 1980s, there were reports of multiple incidents of transmission of the degenerative neurologic disorder, Creutzfeld- 3](https://iiif.wellcomecollection.org/image/b32221514_0068.jp2/full/800%2C/0/default.jpg)
