FDA Guidance Documents Impacting Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Welcome back!
If you’ve been following the Food and Drug Administration (FDA), on January 6, 2025, the FDA released not one, but six guidance documents for the HCT/P industry. But wait – how does this impact the tissue industry? We’ll take a deeper dive individually into each document as we have more information, but hold on to your water bottles as we run into a quick summary of each of these guidance documents!
The guidance document, “Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” revisits the general donor eligibility requirements from 21 CFR Part 1271, with changes from the previous guidance document from August 2007. Proposals to reduce certain deferrals based on time were provided, and looked at donors using individual risk-based questions as a whole, instead of based on gender or sex. Additionally, FDA recommended using an approved FDA licensed donor screening test that includes the detection of the anti-HIV-I group O, versus their previous recommendation to screen for HIV-1 group O risk.
The guidance documents for HIV, Hepatitis B (HBV), and Hepatitis C (HCV), were also released to discuss reducing the risk of transmission of specific relevant communicable disease agents and diseases (RCDADs) for donors. Other guidance documents released were for Sepsis and Mycobacterium tuberculosis (Mtb), for specific screening and testing recommendations, as these two areas have increased for concerns within the transplantation industry. The Mtb guidance emphasizes and provides recommendations for risk factors of infection, conditions, clinical or physical evidence, testing, and implementing additional ways to reduce risk. The Sepsis guidance also includes screening for clinical signs and risk factors, as well as testing for evidence of sepsis.
What are the next steps? Great question!
AATB’s Physician’s Council is working through Sepsis and Mtb, as well as the TPG Regulatory and Quality groups to perform a comprehensive review of all of these documents, and provide clarification from concerns and issues raised to FDA from these guidance documents (1).
But wait – there’s more! FDA also intends to issue separate guidance documents with recommendations regarding reducing the risk of transmission for human transmissible spongiform encephalopathies, cytomegalovirus, Chlamydia trachomatis and Neisseria gonorrhoeae, human T-lymphotropic virus, Treponema pallidum (syphilis), vaccinia virus, West Nile virus, and communicable disease risks associated with xenotransplantation (2) .
Keep following us as we will continue to dive into each guidance document in future blog posts and provide updates as they become available! As always, please reach out to us with any questions and we would be happy to assist your organization in implementation of these changes!
https://www.solaris-srb.com/contact
Copies of the guidance documents can be found here for reference:
https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents
References:
(1) American Association of Tissue Banks website
(2) FDA.gov – Recommendations for Determining Eligibility of Donors of HCT/Ps January 2025