Regulatory

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Regulation and Standards

  • The tissue profession in the United States is governed by mandatory requirements enforced by federal and state regulatory authorities. The authorization of the gift of tissues is governed by the Uniform Anatomical Gift Act.
  • Tissue banks in the United States are governed by the National Organ Transplant Act (NOTA), which dictates that tissues cannot be bought or sold. The law does allow for reimbursement of costs associated with the recovery, processing and storing of tissue and for the development of tissue processing technologies. These activities can include research, screening and testing, sterilization processes and precision-tooled shaping of allografts for transplantation.
  • Regardless of their status, all tissue banks must meet the same regulatory requirements and have the same goal of assisting in the process of making tissue safely available for transplants. Human tissue processed and distributed for transplantation by AATB-accredited tissue banks is subject to Food and Drug Administration (FDA) regulation and AATB's Standards. There are multiple layers of screening, testing, quality assurance and quality control measures in place that help ensure that tissue is safe for transplant.

Tissue Tracking

  • The FDA and AATB's Standards require tracking tissue from the moment of recovery through all handling and distribution to the consignee, the entity that takes the final delivery of the tissue graft.
  • The FDA encourages but does not require the consignee to track the tissue to final disposition, such as use in a patient.
  • AATB's Standards require that members have a protocol in place that provides recipient follow-up data collection, supporting this process by providing an information card that describes use for the consignee to complete and return. However, such participation by end users is voluntary.
  • It is important to emphasize that the foreign recovery operations of firms registered with the FDA are regulated and inspected by the Agency. All human tissue distributed in the United States is subject to FDA regulation as well as the laws and regulations for each country of donor origin.