21 CFR Part 1271 Regulatory Glossary
This glossary provides educational explanations of regulatory terminology used in the United States regulatory framework governing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271.
These definitions are intended to assist healthcare professionals, compliance reviewers, and regulatory readers in understanding terminology referenced in federal tissue regulations, FDA guidance documents, and related regulatory discussions.
Regulatory Terms
HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product)
A category of biological material regulated under 21 CFR Part 1271 that includes certain human tissues and cellular materials intended for implantation, transplantation, infusion, or transfer into a human recipient.
Section 361 HCT/P
A category of HCT/P regulated primarily to control communicable disease transmission when specific regulatory criteria defined under 21 CFR 1271.10(a) are satisfied.
Additional explanation is available in the Section 361 vs Section 351 regulatory comparison.
Section 351 Biological Product
Products that do not satisfy the criteria for regulation solely under Section 361 and therefore fall under the biologics regulatory pathway requiring additional FDA authorization.
Minimal Manipulation
Processing that does not alter the original relevant characteristics of structural tissue or the biological characteristics of cells or non-structural tissue.
Further explanation is available in Minimal Manipulation Under 21 CFR 1271.
Homologous Use
Homologous use refers to situations where a human cell or tissue product performs the same basic function in the recipient as it performed in the donor.
Further discussion is available in Homologous Use Interpretation.
Structural Tissue
Structural tissue refers to tissue that primarily serves a structural or supportive role within the body, including cushioning, covering, or mechanical support.
More detail is discussed in Structural vs Cellular Tissue Classification.
Donor Eligibility Determination
A regulatory process defined under 21 CFR 1271 Subpart C used to evaluate potential communicable disease risks associated with a tissue donor.
More detail is available in Donor Eligibility Requirements.
Current Good Tissue Practice (cGTP)
Regulations under 21 CFR 1271 Subpart D establishing operational requirements governing tissue recovery, processing, storage, labeling, packaging, and distribution.
More information is provided in Current Good Tissue Practice Overview.
Traceability
Traceability refers to the ability to track tissue products through the supply chain from donor recovery through processing and final distribution.
Regulatory References
This information is provided for educational purposes only.
Certain referenced materials may be regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271.
Establishment registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.
This information is not intended to diagnose, treat, cure, or prevent any disease.