21 CFR 1271.10(a) — Classification Criteria Under Section 361
21 CFR 1271.10(a) defines the regulatory criteria used to determine whether a Human Cell, Tissue, or Cellular and Tissue-Based Product (HCT/P) may be regulated solely under Section 361 of the Public Health Service Act.
These criteria are applied within the broader framework established under 21 CFR Part 1271.
Evaluation under this section focuses on product characteristics, processing methods, and intended use as reflected in labeling and related materials.
Core Classification Criteria
An HCT/P may be considered for regulation under Section 361 when all of the following criteria are met:
- Minimal manipulation
- Homologous use
- Not combined with another article, except for water, crystalloids, or sterilizing, preserving, or storage agents
- Does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function (with limited exceptions)
All criteria must be evaluated together when considering regulatory classification.
Role Within the Regulatory Framework
21 CFR 1271.10(a) operates as a central classification checkpoint within the HCT/P regulatory system.
Products that meet these criteria may be regulated solely under Section 361, while products that do not meet these criteria may be subject to additional regulatory pathways.
Further classification context is outlined in: Section 361 vs Section 351 overview .
Documentation and Evaluation Considerations
Evaluation of classification criteria may include review of:
- Processing methods and handling procedures
- Intended use as reflected in labeling and materials
- Donor eligibility and communicable disease controls
- Manufacturing and quality systems under Current Good Tissue Practice (cGTP)
These elements support structured documentation review within a regulatory context.
Related Regulatory Concepts
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.