The overall risk of disease transmission through tissue transplantation is believed to be very low. Information on Keeping Human Tissue Transplants Safe can be found at CBER's website: http://www.fda.gov/fdac/features/2005/305_tissue.html. FDA has been working to help ensure the safety of human tissues since it first required donor testing in 1993. Beginning in 2001, certain establishments involved in manufacturing HCT/Ps were required to register and list their products with FDA. On May 25, 2005, the Current Good Tissue Practice rule requiring certain establishments to use methods and controls to prevent the transmission of communicable disease by HCT/Ps became effective. FDA's new requirements to determine donor eligibility, which also went into effect on May 25, 2005, include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues. | 
