Update from FDA- Delayed Implementation Date for Sepsis and Mtb Guidance Documents

Thanks for joining us! As we’ve been following the Food and Drug Administration (FDA), another hot topic is the release of the guidance document with sepsis, with immediate implementation (on January 6, 2025), “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)”. This information supersedes the previous sepsis information in the guidance document “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry, August 2007”. This came in response due to safety concerns of transmission of Mycobacterium tuberculosis (Mtb) in recipients of bone products, and guess what? Mtb is a disease agent that can cause sepsis (check out our upcoming blog on Mtb)! What’s all the commotion? Per the American Association of Tissue Banks (AATB), this guidance document (in addition to the Mtb document released) was issued without public comment and recommended by FDA for a quick implementation timeframe of 4 weeks after it was released, which is not practical for establishments to meet.

Reference this link for AATB’s response on January 16, 2025:

https://www.aatb.org/news/aatb-leads-effort-address-fda-mtb-and-sepsis-final-guidance-documents-trump-administration-hhs

You can find AATB’s Letter to the FDA here:

https://www.aatb.org/government-advocacy-correspondences

With their push of concerns and challenges impacting the tissue industry in this short timeframe, they were successful in reaching an agreement with the FDA for an extended time in implementation of these guidance documents for establishments (now due by May 4, 2025), reference this link from AATB here:

https://www.aatb.org/news/fda-revises-implementation-date-sepsis-and-mtb-guidance

FDA updated the Federal Register with this implementation timeline here:

https://www.federalregister.gov/documents/2025/02/03/2025-02167/guidance-for-industry-recommendations-to-reduce-the-risk-of-transmission-of-disease-agents

Check back next time for more updates, including dedicated blogs analyzing the requirements within the Sepsis and Mtb guidances!