Homologous Use — Interpretation Examples Under 21 CFR Part 1271

Within the 21 CFR Part 1271 regulatory framework, homologous use is a key criterion used to evaluate whether a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) may qualify under Section 361.

Homologous use is defined under 21 CFR 1271.3(c) as the use of a product to perform the same basic function in the recipient as in the donor.

Core Concept of Homologous Function

For structural tissues, homologous use is generally evaluated based on whether the product provides support, protection, cushioning, or covering consistent with its original function.

Additional regulatory context: Structural vs Cellular Tissue →

Interpretation Considerations

Homologous use evaluation depends on alignment between:

• Original function in the donor tissue
• Intended use in the recipient
• Labeling and documentation statements

Differences between these elements may introduce classification considerations.

Illustrative Interpretation Examples

Aligned Functional Use

Use of structural tissue for support, covering, or cushioning functions consistent with the original biological role may align with homologous use principles.

Function Mismatch Considerations

Use that differs from the tissue’s original basic function may require additional regulatory evaluation and may not meet homologous use criteria.

Relationship to 21 CFR 1271.10(a)

Homologous use is one of the criteria evaluated under 21 CFR 1271.10(a) when determining regulatory classification.

Additional criteria include:

• Minimal manipulation
• Combination limitations
• Systemic effect considerations

Documentation & Labeling Context

Evaluation of homologous use is supported by documentation including:

• Product labeling
• Instructions for use
• Manufacturer documentation
• Clinical context of application

Further documentation considerations: Structured Supplier Evaluation →

Regulatory Context

Homologous use must be evaluated within the broader regulatory framework governing HCT/P classification and documentation.

Additional reference: Section 361 vs Section 351 →