Donor Screening, Traceability & Quality Standards
HCT/Ps regulated under 21 CFR Part 1271 Section 361 are subject to defined donor eligibility determination, communicable disease testing requirements, establishment registration, and Current Good Tissue Practice (cGTP) standards.
This page provides an educational overview of donor eligibility determination under 21 CFR 1271 Subpart C, communicable disease control requirements, lot traceability standards, and Certificate of Analysis (COA) documentation practices relevant to Section 361 HCT/P compliance.
Donor Eligibility Determination — 21 CFR 1271 Subpart C
Donor eligibility determination under 21 CFR 1271 Subpart C is required for HCT/Ps regulated through the communicable disease control pathway of Section 361.
- Medical history review
- Behavioral risk assessment
- Communicable disease risk factor evaluation
- Required laboratory testing
Donor eligibility determination is a core component of the Section 361 HCT/P regulatory structure and supports communicable disease transmission risk mitigation.
Additional classification considerations are discussed in HCT/P Classification under 21 CFR 1271.
Communicable Disease Testing Requirements
HCT/P communicable disease testing requirements under 21 CFR 1271.80 require testing to be performed by appropriately certified laboratories.
These requirements form part of the communicable disease control pathway distinguishing Section 361 HCT/Ps from Section 351 biological product pathways.
Regulatory distinctions are further explained in our Section 361 vs Section 351 overview.
Current Good Tissue Practice (cGTP) — 21 CFR 1271 Subpart D
Current Good Tissue Practice (cGTP) requirements under 21 CFR 1271 Subpart D establish operational controls applicable to HCT/P establishments.
- Facility controls and environmental monitoring
- Equipment validation and process controls
- Personnel training standards
- Deviation management and complaint handling
cGTP compliance does not constitute FDA approval, but it is required for Section 361 HCT/P establishments.
Governance safeguards are outlined in our Governance & Compliance Policy.
Chain-of-Custody & Lot Traceability
HCT/P traceability requires maintenance of lot identification, processing records, and distribution documentation to ensure accountability throughout the supply chain.
- Lot identification numbers
- Recovery site documentation
- Processing and storage records
- Distribution tracking systems
Traceability supports communicable disease control and cGTP compliance under the Section 361 regulatory pathway.
Certificate of Analysis (COA) for HCT/P
A Certificate of Analysis (COA) for an HCT/P may document sterility testing, identity verification, and quality control parameters associated with lot release.
A COA does not constitute FDA approval but may support documentation review under Current Good Tissue Practice (cGTP).
Providers remain responsible for independent regulatory review consistent with Section 361 classification standards.
Educational reference only. Certain products may be regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271 Section 361. Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.