Section 361 HCT/P Criteria — 21 CFR 1271 Overview | Not By Chance Life

Section 361 HCT/P Criteria — 21 CFR 1271 Overview

For the complete regulatory framework and classification structure, refer to: 21 CFR Part 1271 Regulatory Framework .

21 CFR Part 1271 establishes the United States federal regulatory framework governing certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Section 361 of the Public Health Service Act defines a regulatory pathway under which qualifying HCT/Ps may be regulated solely for communicable disease transmission control rather than as drugs, devices, or biological products.

Within this framework, regulatory oversight focuses on donor eligibility determination, establishment registration, manufacturing safeguards, and compliance with Current Good Tissue Practice (cGTP) standards intended to prevent the transmission of communicable diseases.

This page provides an overview of Section 361 classification criteria and its role within the broader regulatory structure.

Regulatory Framework Navigation

Section 361 HCTP regulatory framework overview illustrating qualification criteria under 21 CFR Part 1271 including minimal manipulation homologous use donor eligibility and communicable disease control safeguards
Educational overview illustrating Section 361 qualification criteria under the 21 CFR Part 1271 regulatory framework.

What Is a Section 361 HCT/P?

An HCT/P refers to articles containing or consisting of human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient.

A Section 361 HCT/P is one that meets specific regulatory criteria allowing it to be regulated solely under 21 CFR Part 1271 through communicable disease transmission control safeguards.

Section 361 Qualification Criteria

To qualify as a Section 361 HCT/P, products must satisfy criteria defined in 21 CFR 1271.10(a).

  • Minimal manipulation
  • Homologous use
  • Not combined with another article (with limited exceptions)
  • No systemic effect or reliance on metabolic activity of living cells for primary function (with limited exceptions)

Products that do not meet these criteria may be subject to regulation under Section 351.

Donor Eligibility & Communicable Disease Safeguards

Section 361 HCT/Ps are regulated through donor eligibility requirements and broader safeguards intended to reduce communicable disease transmission risk.

See: Subparts A–D regulatory structure

Establishment Registration Requirements

Establishments involved in handling HCT/Ps must comply with registration and listing requirements under 21 CFR Part 1271.

Registration does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.

Regulatory Distinction: Section 361 vs Section 351

Products not meeting Section 361 criteria may be regulated under Section 351 and subject to additional regulatory requirements.

View Detailed Comparison
FDA Enforcement Overview

Next Step — Structured Evaluation

Classification under Section 361 requires evaluation across multiple regulatory criteria and documentation standards.

View Regulatory Evaluation Pathway →

This information is for educational purposes only. Not evaluated by the FDA. Not intended to diagnose, treat, cure, or prevent any disease. Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness. For use by licensed medical professionals.