🏥FDA Issues Guidance on Reducing Disease Transmission Risks
Guidance for Industry; Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory document outlines revised guidance for businesses involved in handling human cells and tissues related to sepsis and tuberculosis. This presents compliance and regulatory requirements that affect operational procedures and timelines for implementation, impacting business practices and potential liabilities.