HCT/P Regulatory Evaluation Pathway | 21 CFR Part 1271 & Section 361 Framework

HCT/P Regulatory Evaluation Pathway

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) are regulated in the United States under the framework established in 21 CFR Part 1271. Regulatory classification depends on whether a product meets the eligibility criteria described in 21 CFR 1271.10(a).

Understanding the regulatory evaluation pathway helps explain how products may be regulated either under Section 361 of the Public Health Service Act or under the biologics licensing framework associated with Section 351.

The evaluation pathway is not a single regulatory test. Rather, it represents a structured review of the criteria defined throughout 21 CFR Part 1271 that collectively determine the applicable regulatory pathway.

Regulatory evaluation pathway diagram illustrating how Human Cells, Tissues, and Cellular and Tissue-Based Products are assessed under 21 CFR Part 1271 to determine whether they fall under Section 361 HCT/P regulation or Section 351 biologics regulation.

Educational diagram illustrating the regulatory evaluation pathway used when assessing how Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) may be classified under 21 CFR Part 1271.

Initial Regulatory Evaluation

When evaluating an HCT/P, multiple regulatory criteria are considered together to determine whether the product may qualify for regulation solely under Section 361 of the Public Health Service Act.

  • Minimal Manipulation
  • Homologous Use
  • Whether the product is combined with another article
  • Whether systemic effects or reliance on the metabolic activity of living cells are involved

If all regulatory criteria described in 21 CFR 1271.10(a) are satisfied, the product may fall within the Section 361 regulatory framework.

Section 361 Regulatory Pathway

Products that meet all criteria in 21 CFR 1271.10(a) may be regulated solely under Section 361 of the Public Health Service Act.

Establishments handling these products remain subject to regulatory safeguards that may include donor eligibility determination, establishment registration, and compliance with Current Good Tissue Practice (cGTP) requirements.

Section 351 Regulatory Pathway

If an HCT/P does not satisfy one or more of the criteria outlined in 21 CFR 1271.10(a), it may be regulated as a biological product under Section 351 of the Public Health Service Act.

Products regulated under Section 351 are subject to the regulatory requirements applicable to biological products, which may include Investigational New Drug (IND) authorization, Biologics License Application (BLA) requirements, and additional regulatory review, depending on the product and its intended use.

Regulatory Criteria Frequently Examined

Importance of Understanding the Evaluation Framework

Healthcare professionals, regulatory specialists, tissue establishments, and supplier evaluation teams may review the regulatory evaluation framework when assessing compliance considerations related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

Understanding how the individual regulatory criteria interact provides important context for documentation review, supplier evaluation, and regulatory education under 21 CFR Part 1271.

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. 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.

For use by licensed medical professionals.