REGULATORY UPDATE: FDA Withdraws Previously Issued Final Guidances on Tuberculosis and Sepsis, Reissues Both as Draft Guidances
May 05, 2025
As initially published, the January guidances called for implementation “as soon as feasible, but not later than four weeks after the guidance issue date.” In February, FDA revised the implementation date to May 2025.
To assist members with reviewing, AABB has prepared crosswalk documents to highlight the updates in both the
Mtb guidance and the
sepsis guidance.
The draft guidance documents remain largely consistent with the withdrawn final guidances but include several notable revisions:
Mtb Draft Guidance:
- The withdrawn final guidance medical history consideration addressed “persons who… ever traveled to areas of the world where TB is common.” The draft guidance now describes “persons who… frequently traveled to areas of the world where TB is common.
- The new draft guidance states that communication with the donor’s primary treating physician is necessary when the donor falls into one of four risk categories and when “there is physical evidence or a suspicion of LTBI or TB disease, and when feasible and appropriate.”
- The new draft guidance stipulates that “if a living donor appears healthy and there is no suspicion or medical history of LTBI or TB disease (including no prior medical diagnosis of TB disease or LTBI, and no positive test for TB infection), the donor is not considered to have a risk of TB infection.”
Sepsis Draft Guidance:
- FDA revised the recommendations for screening donors for risk of sepsis to focus more narrowly on individuals who “currently, are known to have a medical diagnosis of sepsis or suspicion of sepsis from their most recent healthcare facility stay or visit preceding HCT/P recovery that is not documented as resolved.”
AABB will consider comments to the draft guidances. Please submit comments or questions to
regulatory@aabb.org.
