21 CFR 1271.10(a) — Classification Criteria Under Section 361
21 CFR 1271.10(a) defines the criteria used to determine whether a human cell or tissue product (HCT/P) may be regulated solely under Section 361 of the Public Health Service Act.
To qualify, a product must meet all required criteria including minimal manipulation, homologous use, and defined regulatory limitations.
21 CFR 1271.10(a) defines the criteria used to evaluate whether a human cell or tissue product (HCT/P) qualifies for regulation solely under Section 361 of the Public Health Service Act.
These criteria serve as a classification framework for determining whether an HCT/P may be regulated through communicable disease transmission controls rather than being subject to additional regulatory pathways.
Not sure how these requirements apply to your current sourcing or protocols?
Core Classification Criteria
All of the following criteria must be 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)
Failure to meet any one of these criteria may result in the product being regulated under a different regulatory pathway.
Regulatory Context
These criteria are part of the broader regulatory framework established under 21 CFR Part 1271.
They are used to evaluate product characteristics, processing methods, and intended use.
Related Concepts
Disclaimer
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.