Human cells and tissues: building a 21 CFR 1271 record you can trace
Confirm whether the product is a 361 HCT/P, hold it until donor eligibility is decided, and trace it from donor to consignee.
In Short
- All four 1271.10 criteria apply.
- Keep records 10+ years.
- Deviation report within 45 days.
The Blood and Tissue Guide
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- Which rules reach your unit
- Receive, identify, quarantine
- Process, test, review
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The Blood and Tissue Guide
Every unit identified. Every decision reviewed.
21 CFR Part 1271 regulates human cells, tissues and cellular and tissue-based products (HCT/Ps). Section 1271.10 sets the criteria for products regulated solely under section 361 of the PHS Act; products that do not meet them are also regulated as drugs, devices or biologics. Subparts C and D set donor eligibility and current good tissue practice. This review read the current eCFR text of Part 1271; blood component rules in 21 CFR 606 and 630 were not opened. This guide summarises the sources named here; it is orientation, not legal advice. Sources checked 5 Oct 2026.
Is the product a 361 HCT/P?
Section 1271.10(a) lists four criteria: minimal manipulation, homologous use only, no combination with another article except water, crystalloids or a sterilising, preserving or storage agent that raises no new safety concern, and either no systemic effect and no dependence on living cells' metabolic activity, or autologous, first- or second-degree relative or reproductive use. All four must be met.
Section 1271.10(a) criteria (all must be met)
More on is the product a 361 HCT/P?
Your regulatory team documents the analysis, because a product outside them needs the drug, device or biologic pathway too.
Donor Eligibility and Quarantine
Subpart C requires a donor-eligibility determination based on screening and testing for relevant communicable diseases. Under section 1271.60 the HCT/P stays in quarantine until that determination is complete, clearly identified and easily distinguishable from released material.
More on donor Eligibility and Quarantine
A responsible person makes the determination and signs it. Keep screening, test results and the determination together with the product's identity so the release reviewer sees the whole picture.
Tracking from donor to consignee and back
Section 1271.290 requires a tracking system that follows each HCT/P from the donor to the consignee or final disposition, and back again. Each HCT/P gets a distinct identification code relating it to the donor and to all records.
Worked Example: Tracking Tissue Graft TG-4471
| Step | Record | Links to |
|---|---|---|
| Donor screening and testing | Eligibility determination, signed | Donor ID D-2210 |
| Processing and quarantine | Distinct identification code TG-4471 | Donor and processing records |
| Distribution | Written tracking notice to consignee | Hospital H-18 |
- Donor screening and testing
- Record
- Eligibility determination, signed
- Links to
- Donor ID D-2210
- Processing and quarantine
- Record
- Distinct identification code TG-4471
- Links to
- Donor and processing records
- Distribution
- Record
- Written tracking notice to consignee
- Links to
- Hospital H-18
More on tracking from donor to consignee and back
At or before distribution you must tell the consignee in writing about the tracking requirements and your system. Establishments doing only some steps may join another establishment's tracking system if it meets the section.
Records and the 10-Year Rule
Section 1271.270 requires records made concurrently with each step, accurate, indelible and legible, identifying the person and date, and detailed enough to relate to the particular HCT/P. A records management system must allow review of an HCT/P's history before distribution and during follow-up investigation.
More on records and the 10-Year Rule
Records for a particular HCT/P are kept at least 10 years after administration, or, if unknown, after distribution, disposition or expiration, whichever is latest.
Adverse Reactions and Deviations
Section 1271.350 requires investigation of adverse reactions involving a communicable disease. Reactions that are fatal, life-threatening, cause permanent impairment or need medical or surgical intervention are reported on Form FDA 3500A within 15 calendar days of initial receipt, with follow-up reports within 15 days of new information.
Reporting timelines (section 1271.350)
| Event | Form | Due |
|---|---|---|
| Reportable adverse reaction | FDA 3500A | Within 15 calendar days of initial receipt |
| New information on that reaction | Follow-up report | Within 15 calendar days |
| Reportable HCT/P deviation | FDA 3486 | Within 45 days of discovery |
- Reportable adverse reaction
- Form
- FDA 3500A
- Due
- Within 15 calendar days of initial receipt
- New information on that reaction
- Form
- Follow-up report
- Due
- Within 15 calendar days
- Reportable HCT/P deviation
- Form
- FDA 3486
- Due
- Within 45 days of discovery
More on adverse Reactions and Deviations
Reportable HCT/P deviations relating to a core CGTP requirement go on Form FDA 3486 within 45 days of discovery. People decide reportability and record the reasoning.
Questions
What makes an HCT/P a 361 product?
Meeting all four criteria in 21 CFR 1271.10(a), including minimal manipulation and homologous use. Otherwise it is also regulated as a drug, device or biologic.
How long must HCT/P records be kept?
At least 10 years after administration, or if that date is unknown, 10 years after distribution, disposition or expiration, whichever is latest (section 1271.270).
When is an HCT/P deviation reported?
Reportable deviations relating to a core CGTP requirement are reported on Form FDA 3486 within 45 days of discovering the event (section 1271.350(b)).
Can an HCT/P leave quarantine before donor eligibility is decided?
Generally no. Section 1271.60 keeps it in quarantine until the determination is complete; limited exceptions in section 1271.65 need separate review.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
AABB Blood Bank Standards and 21 CFR 606 Readiness Guide
CAR T Cell Manufacturing Readiness: Chain of Identity and Release
Cord Blood Bank cGMP Readiness: 1271, BLA and FACT-NetCord
Donor Eligibility, Lookback and Deviation Readiness
EU Tissues and Cells Directive 2004/23/EC and the SoHO Regulation
FACT-JACIE Accreditation Readiness for Cell Therapy