American Association of Tissue Banks Accreditation
The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific and educational organization. It is the only national tissue banking organization in the United States, and its membership totals more than 100 accredited tissue banks and 1,000 individual members. These banks recover tissue from more than 30,000 donors and distribute in excess of two million allografts for more than one million tissue transplants performed annually in the U.S. The overwhelming majority of the human tissue distributed for these transplants comes from AATB-accredited tissue banks.
Department of Health and Human Services, Food and Drug Administration Registration
On January 19, 2001, the Food and Drug Administration published a registration and listing final rule that requires human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products (HCT/Ps). The final rule, 21 CFR Part 1271, became effective on April 4, 2001 for human tissues intended for transplantation that are regulated under section 361 of the PHS Act and 21 CFR Part 1270. The final rule became effective on March 29, 2004 for all other HCT/Ps except that registration and listing requirements related to human dura mater and heart valves became effective when the remaining parts of 21 CFR Part 1271 were implemented on May 25, 2005.