21 CFR Part 1271 Subparts A–D | HCT/P Regulatory Structure

21 CFR Part 1271 — Subparts A–D Regulatory Structure

Not By Chance Life infographic illustrating 21 CFR Part 1271 Subparts A through D regulatory structure for HCT/Ps — Educational infographic — 21 CFR Part 1271 Subparts A–D (Not By Chance Life)

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulated under 21 CFR Part 1271 Section 361 operate within a structured regulatory framework established under 21 CFR Part 1271.

Part 1271 is organized into multiple regulatory subparts that define establishment responsibilities, donor eligibility safeguards, and manufacturing controls applicable to HCT/Ps.

For a complete overview of the regulatory framework governing Human Cells, Tissues, and Cellular and Tissue-Based Products, see: 21 CFR Part 1271 Explained.

Professional Documentation Requests

Licensed medical professionals, healthcare institutions, and regulatory compliance teams evaluating Human Cells, Tissues, and Cellular and Tissue-Based Products may request structured documentation regarding regulatory framework interpretation, supplier transparency standards, and compliance review processes referenced throughout this educational resource.

Documentation review may include regulatory framework summaries, supplier evaluation standards, donor eligibility safeguards, manufacturing quality system controls, and chain-of-custody documentation available to qualified healthcare professionals.

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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.

Overview of the Regulatory Framework

Subpart A — General Provisions
Subpart B — Registration & Listing
Subpart C — Donor Eligibility Determination
Subpart D — Current Good Tissue Practice (cGTP)

Qualification under Section 361 requires compliance with the criteria defined in 21 CFR 1271.10(a).

Regulatory classification differences are further explained in the Section 361 vs Section 351 regulatory overview.

Subpart A — General Provisions

Subpart A establishes core regulatory definitions used throughout the HCT/P regulatory framework.

Definition of Human Cells, Tissues, and Cellular and Tissue-Based Products
Minimal manipulation definition (21 CFR 1271.3(f))
Homologous use definition (21 CFR 1271.3(c))
Eligibility criteria under 21 CFR 1271.10(a)

Interpretation of these definitions is discussed in:

Subpart B — Registration & Listing

Subpart B requires establishments involved in manufacturing HCT/Ps to register with the FDA and list each product manufactured.

FDA establishment registration
Product listing requirements
Annual registration updates

Registration under Part 1271 is a reporting requirement and does not represent FDA approval.

Subpart C — Donor Eligibility Determination

Subpart C establishes safeguards designed to reduce the risk of communicable disease transmission through human tissue products.

Donor medical history screening
Behavioral risk assessment
Communicable disease laboratory testing
Documentation and record retention

A detailed overview is available in Donor Eligibility Requirements.

Subpart D — Current Good Tissue Practice (cGTP)

Current Good Tissue Practice regulations establish manufacturing safeguards designed to prevent contamination or communicable disease transmission during recovery, processing, storage, labeling, packaging, and distribution.

Facility environmental monitoring
Quality system controls
Complaint tracking procedures
Deviation investigation processes
Lot traceability systems

A detailed overview is available in the Current Good Tissue Practice (cGTP) overview.