Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
The FDA (CBER) regulation for human cells, tissues, and cellular and tissue-based products. It covers establishment registration, donor eligibility, and Current Good Tissue Practice (CGTP) — the controls that prevent the introduction, transmission, or spread of communicable disease through HCT/Ps.
What this does not cover
stated in the document's own scope- Covers HCT/Ps; whole organs for transplantation, vascularized human organs, and certain other products are excluded from Part 1271.
- The CGTP and Section 361 controls do not by themselves cover HCT/Ps that also require premarket approval as drugs, devices, or biologics — those carry additional requirements.
- Governs communicable-disease prevention and tissue practice, not the clinical use of the product, which falls to the treating practitioner and the applicable practice standards.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 1271 is the FDA regulation for human cells, tissues, and cellular and tissue-based products — HCT/Ps such as corneas, bone, skin, heart valves, reproductive tissue, and some cell therapies. It brings these products under a single framework built around three pillars: registration and listing of the establishments that handle them, donor-eligibility determinations based on screening and testing for relevant communicable diseases, and Current Good Tissue Practice governing the methods, facilities, and controls used in recovery, processing, storage, labeling, and distribution. The unifying purpose across all three is to prevent the introduction, transmission, or spread of communicable disease.
Scope & applicability
Establishments that manufacture HCT/Ps — recover, process, store, label, package, or distribute human cells and tissues.
Legal basis & how it acquires force
Part 1271 is a binding regulation in Title 21 CFR, administered by the Center for Biologics Evaluation and Research. Its authority is split: the communicable-disease provisions rest on Section 361 of the Public Health Service Act, while HCT/Ps that fall outside the criteria for regulation solely under Section 361 are also regulated as drugs, devices, or biological products under the Federal Food, Drug, and Cosmetic Act and the PHS Act. Which regime applies to a given product is determined by the tiered criteria set out in the regulation itself.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General provisions | Scope, definitions, and the criteria for what is regulated solely under Section 361 |
| Subpart B — Registration and listing | Establishment registration and listing of the HCT/Ps handled |
| Subpart C — Donor eligibility | Donor screening and testing for relevant communicable disease agents |
| Subpart D — Current Good Tissue Practice | Facilities, environmental and process controls, labeling, storage, and records |
| Subparts E–F | Additional requirements, reporting, inspection, and enforcement provisions |
Key requirements
- Register the establishment and list HCT/Ps
- Determine donor eligibility through screening and testing
- Apply Current Good Tissue Practice to prevent contamination and cross-contamination
- Maintain records enabling tracking from donor to recipient
Implementation tips
- Make donor eligibility documentation airtight — it is the first thing CBER examines
- Build donor-to-recipient traceability into every step; recovery gaps are hard to close later
- If the HCT/P is also a drug/biologic/device, layer the corresponding GMP on top of CGTP
Revision notes
The CGTP requirements became effective in 2005, consolidating tissue safety under a single framework; periodically updated as testing expectations evolve.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 1271 defines a tiered system: products meeting the criteria for regulation solely under Section 361 of the PHS Act are subject to registration, donor eligibility, and CGTP alone, while products falling outside those criteria are additionally regulated under the drug, device, or biologics frameworks — meaning premarket review and full cGMP can also apply. It sits alongside the biologics regulations administered by CBER rather than within the ICH/PIC/S GMP harmonisation system.
21 CFR Part 1271: frequently asked questions
Quick answers to common questions about 21 CFR Part 1271.
What are HCT/Ps under 21 CFR Part 1271?
Human cells, tissues, and cellular and tissue-based products — articles containing or consisting of human cells or tissues intended for implantation, transplantation, infusion, or transfer, such as corneas, bone, skin, heart valves, and reproductive tissue.
What is Current Good Tissue Practice (CGTP)?
CGTP is the Subpart D set of controls in Part 1271 governing the methods, facilities, and controls used in the recovery, processing, storage, labeling, and distribution of HCT/Ps, aimed at preventing the introduction, transmission, or spread of communicable disease.
Are all HCT/Ps regulated only under Part 1271?
No. Products meeting the criteria for regulation solely under Section 361 of the PHS Act are subject to registration, donor eligibility, and CGTP; those falling outside the criteria are additionally regulated as drugs, devices, or biologics.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.