Sterility Testing for Section 361 HCT/Ps: Clarifying CGTP Expectations and the Role of CLIA Laboratories to Ensure Patient Safety and Compliance

Proposed Session Description: As the use of minimally manipulated human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated under Section 361 of the U.S. Public Health Service Act continues to expand, sterility testing has become a frequent point of regulatory and operational uncertainty. In the U.S., differing interpretations of whether sterility testing performed in CLIA-certified microbiology laboratories can satisfy current good tissue practice (cGTP) requirements under 21 CFR Part 1271 have led to inconsistent approaches and, in some settings, limited access to testing. Determining the correct methods and quality system governing the laboratory where sterility testing is performed should be a collaboration between the laboratory, medical and quality staff. With an understanding of the applicable regulations, methods and validation requirements, this interprofessional team can evaluate their sterility testing process for adequacy to ensure patient safety and regulatory compliance.
A working group within the AABB Cellular Therapies Section Coordinating Committee (CTSCC), in collaboration with representatives from the American Society of Microbiology (ASM), developed a survey to elucidate the current U.S. sterility testing practices. This session will present the survey results and highlight areas of consistency and variability. It will emphasize roles and responsibilities of processing facilities and testing laboratories and offer practical, risk-based considerations for sterility testing of Section 361 HCT/Ps. The U.S. regulatory framework governing Section 361 HCT/Ps will be reviewed to clarify key distinctions between Section 361 and Section 351 products under FDA oversight. Finally, cGTP expectations for in-process controls particularly sterility testing, validation, documentation, and deviation management will be compared with CLIA high-complexity testing requirements administered by the Centers for Medicare & Medicaid Services (CMS).