What USA FDA 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) requires
FDA 21 CFR Part 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products - HCT/Ps) establishes the regulatory framework for human-derived biological materials used in transplantation, therapy, and regenerative medicine. The framework creates a two-tier regulatory approach: (1) HCT/Ps that meet Section 1271.10 criteria (minimal manipulation, homologous use, no systemic effect, not combined with drug/device) are regulated solely under 21 CFR Part 1271 as 361 HCT/Ps (named after the PHS Act Section 351 and 361); (2) HCT/Ps that do not meet all 1271.10 criteria are regulated as drugs, biologics, or devices under PHS Act Section 351 and require BLA, NDA, or PMA approval. Key requirements: donor eligibility determination, current good tissue practice (cGTP), establishment registration, and HCT/P listing with FDA. This regulation governs tissue banks, cord blood banks, reproductive tissue facilities, eye banks, musculoskeletal tissue banks, cardiovascular tissue banks, and manufacturers of advanced cellular therapies.
Pillar: Biotech & Genomics · Authority: U.S. Food and Drug Administration (FDA) - Center for Biologics Evaluation and Research (CBER) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
SHA-256 integrity: 506c4717371e50e4c4103969445922ac740fd156a49657228ea88501aed0441b
Primary Citations — 7 traced to source
- {"instrument":"21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)","section":"Subpart A - General Provisions (1271.1-1271.20); Subpart B - Registration and Listing (1271.21-1271.37); Subpart C - Donor Eligibility (1271.45-1271.90); Subpart D - Current Good Tissue Practice (1271.145-1271.320); Subpart E - Reporting (1271.350-1271.370)","url":"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271"}
- {"instrument":"FDA Guidance - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (2017)","section":"Criteria for minimal manipulation determination; tissue-specific analysis of processing effect on relevant biological characteristics","url":"https://www.fda.gov/vaccines-blood-biologics/biologics-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products"}
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