What Is an HCT/P?
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) are human-derived biological materials regulated within the framework established under 21 CFR Part 1271.
The regulatory structure governing HCT/Ps was developed to reduce the risk of communicable disease transmission associated with certain human tissue products and to establish safeguards for donor screening, tissue processing, and manufacturing practices.
Regulatory Definition
Under FDA regulations, Human Cells, Tissues, and Cellular and Tissue-Based Products include certain human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient.
The regulatory framework governing these products is established in 21 CFR Part 1271, which defines requirements related to donor eligibility determination, manufacturing safeguards, and regulatory classification.
Examples of Human Tissue Products
Human-derived biological materials that may fall within the HCT/P regulatory framework include:
- Structural connective tissues
- Human extracellular matrix materials
- Placental-derived structural tissues
- Other human tissue grafts intended for structural support or coverage
Regulatory classification may depend on multiple factors including product processing, intended use, and compliance with regulatory criteria.
Section 361 vs Section 351 Regulation
Certain HCT/Ps may qualify for regulation solely under Section 361 of the Public Health Service Act when they meet specific criteria defined in 21 CFR 1271.10(a).
Products that do not meet these criteria are generally regulated under the biologics regulatory pathway described in Section 361 vs Section 351 regulatory analysis.
Donor Eligibility Safeguards
A central component of the HCT/P regulatory framework involves donor eligibility determination designed to reduce the risk of communicable disease transmission.
This process typically involves medical history review, behavioral risk assessment, and communicable disease laboratory testing as outlined in Donor Eligibility Requirements.
Manufacturing Safeguards
Manufacturing safeguards governing HCT/P establishments are defined under Current Good Tissue Practice (cGTP).
These operational standards establish controls governing recovery, processing, storage, labeling, packaging, and distribution of human tissue products.
Regulatory Framework Overview
The full regulatory structure governing Human Cells, Tissues, and Cellular and Tissue-Based Products is summarized in the 21 CFR Part 1271 regulatory overview.
Additional regulatory interpretation resources include the 21 CFR Part 1271 Subparts A–D overview.
Regulatory References
Educational reference only. Certain referenced materials may be regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271. Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness. This information is not intended to diagnose, treat, cure, or prevent any disease. For use by licensed healthcare professionals.