21 CFR Part 1271 Overview — Regulatory Structure and Criteria | Not By Chance Life

21 CFR Part 1271 — Regulatory Structure Overview

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

21 CFR Part 1271 establishes the regulatory framework used by the U.S. Food and Drug Administration (FDA) to oversee Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

This framework defines how these products are evaluated, handled, and distributed, with a primary focus on reducing the risk of communicable disease transmission and ensuring appropriate processing controls.

This page provides a high-level overview of the regulatory structure. Detailed explanations of individual regulatory criteria are provided in the linked sections below.

Diagram illustrating the FDA regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products under 21 CFR Part 1271 including Section 361 eligibility criteria and Section 351 biologics pathway
Overview of how HCT/Ps are evaluated under 21 CFR Part 1271 and related regulatory pathways.

How the 21 CFR 1271 Framework Is Structured

21 CFR Part 1271 is organized into regulatory subparts that define establishment requirements, donor eligibility standards, and manufacturing controls.

  • Subpart A — General Provisions
  • Subpart B — Establishment Registration and Listing
  • Subpart C — Donor Eligibility Requirements
  • Subpart D — Current Good Tissue Practice (cGTP)

Each subpart addresses a specific component of regulatory oversight, forming a coordinated framework governing how HCT/Ps are handled and distributed.

Section 361 vs Section 351 Regulatory Pathways

HCT/Ps are evaluated under criteria defined in 21 CFR 1271.10(a) to determine whether they may be regulated solely under Section 361 of the Public Health Service Act or require regulation under Section 351.

A detailed breakdown of these regulatory pathways is available here: Section 361 vs Section 351 Classification.

Core Regulatory Criteria (21 CFR 1271.10(a))

To qualify for regulation under Section 361, products must meet specific criteria. Each criterion is explained in detail in the following pages:

These criteria are central to how HCT/Ps are classified within the regulatory framework.

Current Good Tissue Practice (cGTP)

Establishments involved in recovery, processing, storage, labeling, packaging, or distribution must comply with Current Good Tissue Practice (cGTP) requirements defined in Subpart D.

These standards address:

  • Processing controls
  • Recordkeeping
  • Quality systems
  • Product tracking and traceability

Additional detail: cGTP Overview

Regulatory Oversight and Enforcement

The FDA monitors compliance through inspections, documentation review, and enforcement actions where applicable.

Regulatory actions may include warning letters, inspection observations, or other measures related to non-compliance with regulatory criteria.

Additional detail: FDA Enforcement Overview

Regulatory Knowledge Map

The following pages expand on specific regulatory components within the 21 CFR Part 1271 framework:

Next Step — Structured Evaluation

Understanding the regulatory structure is one component of classification. A structured evaluation across all criteria may be required when assessing HCT/Ps.

View Regulatory Evaluation Pathway →

Regulatory Notice

This information is for educational purposes only.

Not evaluated by the FDA. Not intended to diagnose, treat, cure, or prevent any disease.

For use by licensed medical professionals.

Registration under 21 CFR Part 1271 does not constitute FDA approval or endorsement.