What laws and regulations govern the recovery, processing and distribution of tissues in the United States?
Human tissues intended for transplantation have been regulated by Food and Drug Administration (FDA) since 1993. In May of 2005, three new, comprehensive regulations went into effect that address manufacturing activities associated with human cells, tissues and cellular and tissue- based products (HCT/Ps). The first requires that companies that produce and distribute HCT/Ps register with the FDA. The second provides criteria that must be met for donors to be eligible to donate tissues and is referred to as the “Donor Eligibility” rule. The third rule governs the processing and distribution of the tissues and is often referred to as the “Current Good Tissue Practices” rule. Together they are designed to ensure that sound, high quality practices are followed to reduce the risk of tissue contamination and of communicable disease transmission to recipients. These rules are available at: FDA – Tissue Guidances.
