FDA Worried Your Donated Organs Might Come With Tuberculosis
Published Date: 1/7/2025
Notice
Summary
The FDA just dropped new rules to help companies that handle human cells and tissues keep tuberculosis (TB) from spreading. These rules tell them how to check donors for TB risks and what extra steps to take until better TB tests are ready. This change starts right away and helps protect everyone who gets these medical products without adding big costs.
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Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
New Donor TB Screening Recommendations
On January 7, 2025, the FDA issued a final guidance that establishments that make donor eligibility determinations for human cells, tissues, and cellular and tissue‑based products (HCT/Ps) should screen donors for evidence of, and risk factors for, Mycobacterium tuberculosis (Mtb) infection. The guidance is immediately available for implementation and is intended to reduce the risk that transplanted HCT/Ps transmit tuberculosis.
Interim Steps Until TB Tests Available
The guidance recommends that HCT/P establishments take additional steps to reduce Mtb transmission risk until appropriate FDA‑licensed, approved, or cleared donor screening tests for Mtb infection are available. These interim recommendations are part of the final guidance that the FDA made available on January 7, 2025.
Mtb Now Identified As RCDAD
The guidance identifies Mycobacterium tuberculosis (Mtb) as a relevant communicable disease agent or disease (RCDAD) under 21 CFR 1271.3(r)(2) and states that it supplements other donor eligibility guidance for HCT/P donors. FDA cites multistate outbreaks in 2021 and 2023 as context for this designation.
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