Since 1993, the FDA has regulated human tissue intended for transplants. As of May 2005, there are three new regulations that address the manufacturing activities associated with human cells, tissues, and cellular and tissue-based products (HCT/Ps).
The first regulation requires companies to register with the FDA if they intend to produce and distribute HCT/Ps.
The second regulation, called the “Donor Eligibility” rule, concerns the donor’s ability to meet certain criteria in order to be eligible to donate tissue.
Finally, the third rule, referred to as the “Current Good Tissue Practices” rule, oversees the overall processing and distribution practices of each company.
As a whole, these rules are implemented to ensure the quality of the tissue and reduce the risk of contamination or disease transmission.