🏥FDA Issues Guidance on Reducing Disease Transmission Risks
The final guidances entitled "Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps)" are being revised to change the time by which FDA recommends implementation of the recommendations in the guidances.
Learn More⚠️FDA Guidance to Reduce Sepsis Risk in Human Cells and Tissues
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled "Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." FDA is issuing this guidance to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of infections due to sepsis by HCT/Ps. This notice is being issued to respond to a public health safety concern and to address the urgent need for updated recommendations in making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.
Learn More🩺FDA Draft Guidance on Reducing Disease Transmission Risks in HCT/Ps
The Food and Drug Administration (FDA or Agency) is announcing the availability of three specific draft guidances for industry entitled "Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" "Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" and "Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." These draft guidances are intended to update existing guidances and to assist establishments making donor eligibility determinations in understanding the requirements for determining donor eligibility, including donor screening and testing, for donors of HCT/Ps. These draft guidances are also intended to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of specific communicable disease agents and diseases, specifically, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), by HCT/Ps.
Learn More🦠FDA Guidance on Reducing Mycobacterium Tuberculosis Transmission Risks
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled "Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." FDA is issuing this guidance to assist establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations for screening donors for evidence of, and risk factors for, infection with Mycobacterium tuberculosis (Mtb), the organism that causes tuberculosis. The guidance also recommends additional steps that HCT/P establishments should take to reduce risk of transmission of Mtb until such time as appropriate FDA-licensed, approved, or cleared donor screening tests are available for use to test donors for Mtb infection. The guidance identifies Mtb as a relevant communicable disease agent or disease (RCDAD) and supplements the recommendations contained in other donor eligibility guidance documents for donors of HCT/Ps. This guidance is being issued to address the urgent public health need to reduce the risk of transmission of Mtb by HCT/Ps.
Learn More🏥FDA Guidance on Donor Eligibility for Human Products Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance document entitled "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This draft guidance document includes general information on determining eligibility for donors of HCT/Ps. In addition, FDA intends to issue separate guidance documents with recommendations regarding reducing the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps. These guidance documents are intended to update an existing guidance.
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