What 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) requires
FDA 21 CFR Part 1271 governs human cells, tissues, and cellular and tissue-based products, setting the criteria under which an HCT/P is regulated solely under section 361 of the Public Health Service Act, requiring establishments to register and list their products, to determine donor eligibility through screening and testing, and to establish and maintain procedures and current good tissue practice to prevent the introduction, transmission, or spread of communicable disease.
Pillar: Medical & Healthcare · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
SHA-256 integrity: 95ea79587d15760df15f37ed84be14dbd4053e75610395f09be4432cea19d292
Primary Citations — 8 traced to source
- § 1271.10: HCT/Ps regulated solely under section 361 of the PHS Act.
- § 1271.15: Exceptions from the requirements of this part.
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