Homologous Use — 21 CFR 1271 Regulatory Standard

Homologous Use Under 21 CFR Part 1271 — Regulatory Standard

Homologous use is a regulatory criterion used by the U.S. Food and Drug Administration (FDA) when evaluating Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

This concept is defined in 21 CFR 1271.3(c) and must be evaluated within the broader framework established under 21 CFR Part 1271.

Homologous use is one of several criteria used to determine whether a product may qualify for regulation solely under Section 361 of the Public Health Service Act.

Regulatory classification criteria are further defined under 21 CFR 1271.10(a) .

It is evaluated alongside minimal manipulation, combination limitations, and systemic effect considerations.

For a structured overview of all regulatory criteria, see the Regulatory Resource Library.

Documentation and Regulatory Education

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Homologous use regulatory evaluation comparing donor tissue function to recipient function under 21 CFR 1271
Educational reference illustrating homologous use evaluation under 21 CFR 1271.3(c).

Regulatory Definition

Homologous use refers to 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.

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

For applied interpretation examples: Homologous use interpretation examples →

Intended Use Evaluation

Regulatory evaluation considers objective evidence of intended use, including:

  • Labeling
  • Website content
  • Promotional materials

Function Alignment Considerations

Structural tissues typically provide:

  • Covering or barrier function
  • Cushioning or support
  • Physical structure

Use must remain consistent with these basic functions to meet homologous use criteria.

Role in Regulatory Classification

Related Regulatory Topics

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.