FDA Revamps Rules to Stop Infections from Body Part Swaps
Published Date: 5/5/2025
Notice
Summary
The FDA is updating its safety advice for people and companies that handle human cells and tissues used in medical treatments. They’re pulling back old rules about stopping infections like sepsis and tuberculosis and sharing new draft versions to get feedback. This means safer products and a chance for industry to weigh in before final rules are set.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Safer human cell and tissue products
The FDA is updating safety advice for people who receive or handle human cells and tissues used in medical treatments by withdrawing prior final guidances and issuing new draft guidances addressing transmission of sepsis and Mycobacterium tuberculosis. The change is intended to reduce the risk that these infections are passed through human cells, tissues, and cellular and tissue‑based products.
Industry can comment on new draft guidances
The FDA withdrew two final guidances titled "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 reissued them as draft guidances so people and companies that handle HCT/Ps can provide feedback before final rules are set.
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