Section 361 vs Section 351 HCT/P Classification — Regulatory Distinction Explained

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) are regulated under 21 CFR Part 1271 Section 361 and the Public Health Service Act.

Regulatory classification determines whether a product qualifies solely under Section 361 (communicable disease control framework) or must be regulated as a biological product under Section 351.

This analysis forms part of the broader Biologic Product Portfolio and directly affects documentation standards, permissible positioning language, manufacturing controls, and potential enforcement exposure.

Section 361 vs Section 351 HCT/P classification comparison chart showing regulatory pathway, FDA approval requirements, clinical trial expectations, manufacturing controls, and enforcement exposure
Educational comparison of Section 361 and Section 351 regulatory frameworks. Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.

Section 361 HCT/P Qualification Criteria

A product may qualify under Section 361 only if it satisfies all criteria outlined in 21 CFR 1271.10(a).

  • Minimal manipulation
  • Homologous use
  • Not combined with another article (with limited exceptions)
  • No systemic effect and not dependent upon metabolic activity for primary function (unless qualifying exception applies)

Establishments operating under Section 361 remain subject to:

The full regulatory structure is outlined within the Subparts A–D framework.

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