AATB and the Tissue Banking Industry: Response to FDA’s Mtb and Sepsis Guidance Documents
Thanks for joining! In previous blogs we were following the Food and Drug Administration’s (FDA) updated guidance documents for the Mycobacterium Tuberculosis (Mtb) and Sepsis, that are currently in their comment period. With these guidance documents up for discussion, who is the American Association of Tissue Banks (AATB) and how does their involvement impact our industry? Let’s dive in!
Background
For those who are in the tissue banking industry, “the American Association of Tissue Banks (AATB) was founded in 1976 by a group of doctors and scientists who had started (in 1949) the United States’ first tissue bank, the United States Navy Tissue Bank. Recognizing the increasing use of human tissue for transplant, these individuals saw the need for a national organization to develop standards, promote ethics and increase donations. Since its beginning, AATB has been dedicated to improving and saving lives by promoting the safety, quality, and availability of donated human tissue. To fulfill that mission, AATB publishes standards, accredits tissue banks, and certifies personnel. The association also interacts with regulatory agencies and conducts educational meetings” [1]
AATB published its Standards for Tissue Banking which are private (and voluntary) tissue banking standards that are comprehensive with a detailed approach to establishing safe tissue practices compliant to federal and state regulations as well as several international directives. AATB fulfills this mission by publishing their standards, accrediting tissue banks, and certifying personnel. They also champion and advocate for the tissue industry through interactions with regulatory agencies and conducting educational meetings.
Foreground
After the FDA initially released the Mtb and Sepsis documents earlier this year in January 2025 requiring immediate implementation (within 4 weeks of their posting), the tissue banking industry pushed back and voiced multiple concerns. The AATB immediately reached out to the FDA to urge the Trump administration to rescind the guidance documents as there was no public comment period and lack of clarification for several concerning areas in these new guidance documents [2] . On February 3, 2025, FDA announced that there would be a revised final version that would be due for implementation by May 4, 2025.
The AATB continued to reach out to the FDA several times urging them to consider rescinding and revising the guidance documents. On April 29, 2025, AATB representatives met with the Office of Management and Budget (OMB) to reiterate the ongoing concerns (also including other healthcare organizations outside of tissue banks) as the recommendations in these documents were ambiguous, complex, or in some cases impossible to implement 2 which would impact the tissue industry and limit access for patients receiving treatments using these tissue products. Recently on May 2, 2025, the FDA reissued the guidance documents for Mtb and Sepsis opening them up for industry stakeholder feedback (i.e., the comment period) due by July 7, 2025.
So why are these timelines important?
Stakeholders have an opportunity to impact the proposed rules and influence the FDA’s regulatory decision based on reasoning and logic. These submissions are reviewed, and the FDA may also schedule public meetings and hearings to further discuss the proposals. Once the FDA has made its final decision, the guidance documents will be sent as “final” and posted in the Federal Register, although the FDA states the guidance documents are “nonbinding”, during regulatory inspections, FDA inspectors reference these guidance documents when they issue 483 observations and warning letters, which essentially requires establishments to implement them immediately. Check back later as we keep up to date following the American Association of Tissue Banks and their correspondence with the Food and Drug Administration on how these guidance documents impact our industry!
References:
[1] https://www.aatb.org/about
[2] https://www.aatb.org/government-advocacy-correspondences