Understanding 21 CFR 1271 Section 361

21 CFR Part 1271 establishes the federal regulatory framework governing certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Section 361 of the Public Health Service Act outlines the regulatory pathway under which a Section 361 HCT/P may be regulated solely for communicable disease control rather than as a drug, device, or biological product.

The Section 361 HCT/P pathway is commonly referred to as the communicable disease control pathway, meaning regulatory oversight primarily focuses on preventing transmission of communicable diseases through donor eligibility determination, establishment registration requirements, and compliance with current good tissue practice (cGTP) standards.

This page forms part of the broader Biologic Product Portfolio and provides structured educational overview of Section 361 HCT/P qualification criteria, the 361 vs 351 distinction, and establishment registration requirements relevant to licensed medical professionals and institutions.

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 the communicable disease control pathway rather than under the biologics licensure pathway.

Section 361 Classification Criteria

For an HCT/P to qualify as a Section 361 HCT/P under 21 CFR Part 1271 , it must generally meet all of the following criteria outlined in 21 CFR 1271.10(a):

• Minimal manipulation
• Intended for homologous use only
• Not combined with another article (with limited exceptions)
• No systemic effect and not dependent upon metabolic activity of living cells for primary function (or meets specific exceptions)

Failure to meet these criteria removes the product from the Section 361 HCT/P classification and may result in regulation under Section 351.

Donor Eligibility & Communicable Disease Controls

Section 361 HCT/Ps are regulated through donor eligibility requirements under Subpart C of 21 CFR Part 1271 and operate within the broader Subparts A–D regulatory structure.

Compliance must be maintained across all applicable subparts of Part 1271.

Establishment Registration Requirements

Establishments that manufacture, process, store, label, package, or distribute Section 361 HCT/Ps must comply with establishment registration requirements outlined in Subpart B of 21 CFR Part 1271.

Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.

Regulatory Distinction: Section 361 vs Section 351

Products not meeting Section 361 HCT/P qualification criteria may be regulated under Section 351 of the Public Health Service Act and subject to biologics licensure, clinical trial requirements, and premarket approval.

Understanding this regulatory distinction is critical for institutions conducting due diligence on biologic product classification.

View Detailed 361 vs 351 Comparison
FDA Enforcement Overview

Professional Documentation & Evaluation Pathway

Not By Chance Life LLC facilitates structured regulatory education and credential-based documentation coordination for licensed healthcare professionals evaluating HCT/P regulatory positioning.

Structured documentation review is available through the Structured Supplier Evaluation Process.

Initiate Credential Verification →

Educational reference only. Certain products may be regulated as Section 361 HCT/Ps under 21 CFR Part 1271. Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness. These materials are not intended to diagnose, treat, cure, or prevent any disease.