HCT/P Regulatory Knowledge Map
The regulatory framework governing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in the United States is established under 21 CFR Part 1271. This framework defines the criteria used to determine whether a product may be regulated solely under Section 361 of the Public Health Service Act or whether it may require regulation under the biologics licensing pathway associated with Section 351.
Key regulatory considerations include minimal manipulation, homologous use, donor eligibility determination, current good tissue practice requirements, and establishment registration.
The sections below provide an educational overview of how these regulatory concepts interact when evaluating tissue-based products.
For a complete regulatory document library, visit the Regulatory Resource Center.
Core Regulatory Criteria Under 21 CFR Part 1271
21 CFR Part 1271 Overview
Introduction to the regulatory structure governing Human Cells, Tissues, and Cellular and Tissue-Based Products.
Section 361 vs Section 351
Explanation of regulatory classification pathways applied to tissue-based products.
Minimal Manipulation
Processing limitations used to determine whether original tissue characteristics remain intact.
Homologous Use
Requirement that a product performs the same basic function in the recipient as in the donor.
Structural vs Cellular Tissue
Regulatory distinction used when evaluating minimal manipulation criteria.
Donor Eligibility Determination
Screening safeguards intended to reduce communicable disease transmission risk.
Current Good Tissue Practice (cGTP)
Operational safeguards governing tissue processing, storage, labeling, and distribution.
Tissue Chain of Custody
Traceability and documentation safeguards supporting regulatory compliance.
Regulatory Evaluation Framework
Structured evaluation approach used when assessing regulatory classification.
FDA Enforcement & Oversight
Overview of regulatory enforcement activity affecting tissue establishments.
Regulatory Interpretation and Oversight
FDA regulatory interpretation is informed by formal guidance documents, enforcement communications, and scientific evaluation of tissue processing practices. Understanding how these elements interact is important when assessing whether a product may qualify for regulation solely under Section 361.
Additional interpretive materials are available through the Regulatory Resource Center, including summaries of FDA guidance documents and regulatory reference materials.