Recommendations for determining the Suitability of Donors for human Cells, Tissues and cell-based Products (HCT/Ps)

The FDA has issued the guidance document ‘Recommendations for Determining Donor Eligibility for Human Cells, Tissues, and Cell-Based Products (HCT/Ps)’ to assist establishments in complying with the regulations at 21 CFR Part 1271, Subpart C. These regulations establish requirements for determining donor eligibility, including the screening and testing of donors to minimise the risk of communicable disease transmission.

The guidance provides general information on determining donor eligibility and emphasises the importance of comprehensive screening and specific testing to identify relevant communicable pathogens and diseases. The FDA also plans to publish separate guidance documents with recommendations to reduce the risk of transmission of specific pathogens and diseases for donors of HCT/Ps, including:

• Human immunodeficiency virus (HIV)
• Hepatitis B virus
• Hepatitis C virus
• Mycobacterium tuberculosis (Mtb)
• Sepsis
• Human transmissible spongiform encephalopathies
• Cytomegalovirus
• Chlamydia trachomatis and Neisseria gonorrhoeae
• Human T-lymphotropic virus
• Treponema pallidum (syphilis)
• Vaccinia virus
• West Nile virus
• Transmissible disease risks associated with xenotransplantation

These additional guidance documents are intended to assist facilities in identifying specific risks and taking appropriate actions to ensure the safety of HCT/Ps.

The FDA emphasises that compliance with the requirements set forth in 21 CFR Part 1271, Subpart C, is essential for all facilities involved in determining donor eligibility. This includes facilities responsible for the screening, testing, and final release of HCT/Ps.

The authority invites interested parties to submit comments on this guidance to allow for continuous improvements and updates based on new scientific evidence and technological advances. It represents FDA's current thinking on this topic and should be considered a recommendation unless specific regulatory or statutory requirements are cited. For more information and the full guidance document please see the official FDA website at "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".