5 May 2025
🧬FDA Draft Guidance on Disease Risks in Human Cells, Tissues
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; Draft Guidances for Industry; Availability
Summary
The Food and Drug Administration (FDA or the Agency) is withdrawing two 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)" and reissuing them as draft guidances.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's draft guidances outline compliance requirements for establishments involved in human cell and tissue products, particularly regarding donor eligibility and disease transmission. Businesses in this sector must adapt to these evolving regulations.