UPDATE: FDA Rescinds Previous Implementation Timelines for Mycobacterium Tuberculosis (Mtb) and Sepsis Guidance Documents, Welcomes Public Comments for Their Revised Draft Documents
Thanks for joining! Have you heard the latest from the Food and Drug Administration (FDA) on these two guidance documents? Originally released as final guidance documents on January 6, 2025, with implementation within four (4) weeks of their releases, these documents were the talk of the industry!
The American Association of Tissue Banks (AATB) reached out to the FDA on January 16, 2025, to urge the Trump administration to immediately rescind the guidance documents as there was no public comment period and lack of clarification for several concerning areas in these new guidance documents [1] .
On February 3, 2025, FDA announced that there would be a revised final version that would be due for implementation by May 4, 2025. Since then, the AATB has continued to pursue several urgent discussions with the FDA over these documents and on May 2, 2025, the FDA withdrew the final guidance documents for Mtb and Sepsis and has reissued these guidance documents with revisions and allowed public comment up to July 7, 2025 [2]
The AATB is currently reviewing these documents in detail and will submit their comments before this deadline.
Check out our upcoming blog as we continue to follow the AATB’s ongoing advocacy efforts with the FDA and how this impacts our industry!
You are also able to download our Mtb and Sepsis crosswalks to review the changes!
References
[2] https://www.fda.gov/regulatoryinformation/search -fda-guidance-documents
Sepsis Crosswalk - Full Document here
Sepsis Crosswalk Page 2