🩺FDA Draft Guidance on Reducing Disease Transmission Risks in HCT/Ps
Draft Guidances Relating to Recommendations To Reduce the Risk of Transmission of Relevant Communicable Disease Agents and Diseases by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The content outlines regulatory requirements from the FDA aimed at reducing the transmission risks of communicable diseases via human cells and tissues. This represents compliance and regulatory requirements for establishments involved in HCT/Ps, emphasizing the importance for business owners to adapt their donor eligibility practices.