Homologous Use Under 21 CFR Part 1271 — Regulatory Standard Explained

Homologous use is a central regulatory criterion determining whether a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) may qualify for regulation solely under 21 CFR Part 1271 Section 361.

The standard is defined in 21 CFR 1271.3(c) and applied together with the eligibility criteria outlined in 21 CFR 1271.10(a).

A product must meet the homologous use requirement in addition to minimal manipulation, non-combination status, and systemic effect limitations to remain within Section 361.

Homologous Use regulatory evaluation framework under 21 CFR 1271 showing donor function identification, intended use comparison, and Section 361 vs 351 decision pathway
Educational regulatory evaluation framework illustrating homologous use analysis under 21 CFR 1271.3(c). Qualification requires satisfying all elements of 1271.10(a).

Regulatory Definition of Homologous Use

Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function in the recipient as in the donor.

The analysis focuses on the original basic function of the tissue in the donor and whether the intended use in the recipient aligns with that function.

  • What is the tissue’s native biological or structural function?
  • What function is intended in the recipient?
  • Do those functions align at a basic level?

FDA Intended Use Evaluation

The FDA evaluates homologous use based on objective evidence of intended use. This includes:

  • Labeling and product descriptions
  • Advertising materials
  • Website content
  • Sales and promotional statements

Claims suggesting functions beyond the tissue’s basic role may alter regulatory classification, regardless of processing status.

Even if a product satisfies minimal manipulation, non-homologous intended use may trigger regulation under Section 351.

Basic Function vs Expanded Interpretation

The FDA distinguishes between:

  • Basic function of the tissue
  • Expanded clinical or therapeutic claims

Structural tissues generally provide support, covering, cushioning, protection, or connective function. Promotion of uses beyond these fundamental properties may affect classification analysis.

For cellular or nonstructural tissues, the analysis focuses on biological role and functional characteristics.

Compliance & Classification Implications

Homologous use must be evaluated together with:

Qualification under Section 361 requires satisfying all criteria under 21 CFR 1271.10(a). Failure to meet any element may require regulation under Section 351 as a biological product.

Section 361 vs Section 351 Comparison
FDA Enforcement Overview

Professional Documentation & Evaluation Access

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

Documentation review and manufacturer discussion coordination are available through the Structured Supplier Evaluation Process.

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Regulatory Notice

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

This content is provided for educational purposes only and does not constitute legal or medical advice.