21 CFR 1271.10(a) — Misclassification Risks & Regulatory Considerations

Under 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) must meet specific criteria defined in 21 CFR 1271.10(a) to qualify for regulation solely under Section 361 of the Public Health Service Act.

This page provides an educational overview of common areas where regulatory misclassification may occur based on interpretation of these criteria.

Overview of 21 CFR 1271.10(a) Criteria

To qualify under Section 361, an HCT/P must generally meet the following conditions:

• Minimal manipulation
• Homologous use
• Not combined with another article (with limited exceptions)
• No systemic effect or dependence on metabolic activity of living cells for primary function

Failure to meet these criteria may result in classification under Section 351.

Common Areas of Misclassification Risk

1. Interpretation of Minimal Manipulation

Misclassification may occur when processing methods alter relevant biological or structural characteristics beyond what is defined as minimal manipulation under 21 CFR 1271.3(f).

2. Homologous Use Interpretation

Homologous use is defined by whether the product performs the same basic function in the recipient as in the donor. Misalignment between intended use and original function may introduce classification risk.

3. Combination with Other Articles

Combining HCT/Ps with additional components outside of limited exceptions may affect regulatory classification.

4. Systemic Effect Considerations

Products that rely on systemic activity or metabolic function of living cells for their primary purpose may not meet Section 361 criteria.

Documentation Considerations

Evaluation of classification should be supported by documentation including:

• Processing methodology descriptions
• Intended use statements
• Donor eligibility documentation
• Chain-of-custody and traceability records

Additional context: Donor Screening & Traceability Standards →

Regulatory Context

Classification is determined through application of regulatory definitions and criteria within the broader 21 CFR Part 1271 framework .

Further detail: Section 361 vs Section 351 →