21 CFR Part 1271: what it is, who needs to comply, and how FDA inspection works

What is 21 CFR Part 1271?

21 CFR Part 1271 is the FDA's regulation for establishments that recover, screen, test, process, store, label, package or distribute human cells, tissues and cellular and tissue-based products, known as HCT/Ps. It requires registration with the FDA, a donor eligibility determination for every donor and current good tissue practice, and compliance is shown to an FDA investigator at inspection.

Subpart B is registration and listing, Subpart C donor eligibility and Subpart D current good tissue practice. Subparts E and F add reporting, labelling and inspection for HCT/Ps regulated solely under section 361 of the Public Health Service Act. The donor eligibility and good tissue practice rules took effect on 25 May 2005. There is no Part 1271 certificate, and the FDA does not accredit tissue establishments.

Who needs to comply with Part 1271?

Tissue banks and establishments that recover, process, store or distribute musculoskeletal, skin, cardiovascular, ocular or reproductive tissue regulated solely under section 361, with no premarket review

Cell and gene therapy companies whose product is also regulated as a biologic, since the donor eligibility and good tissue practice subparts apply alongside the BLA and cGMP

Device companies whose HCT/P is regulated as a device or combined with one, where the donor and tissue practice requirements apply beside the QMSR

The rule becomes urgent when the registration on Form FDA 3356 is due for its annual update, when a donor eligibility determination has to be documented and signed before the tissue leaves quarantine, or when the investigator's list asks for the processing procedures and the training behind them.

PART 1271 IN QUALIO

Qualio maps the donor eligibility, processing and distribution records to the Part 1271 subparts they answer, so the inspector reads donor to dose on the procedures you already follow

Qualio breaks Part 1271 down section by section, beside cGMP and AATB, and maps your procedures, training, donor screening records, deviations, complaints and supplier files to the sections they answer. When a record changes, it reassesses those sections and recommends a fix for each gap. Copilot drafts the deviation write-up or the complaint investigation, and your team approves it. When the investigator asks, you export the evidence by subpart.

Procedures for every step from recovery to distribution held as controlled documents for 1271.180, each revision approved by the person your procedure names, effective on the date you set, with the retraining out that day to everyone who follows it, for 1271.170

Deviations and complaints logged as events against the HCT/P, the procedure and the supplier they concern, each traceable to the investigation and the CAPA that closed it, for the complaint file in 1271.320 and the deviation reporting in 1271.350

Supplier files for the reagents and supplies 1271.210 asks you to verify, qualified once with an audit schedule set by risk, and the donor screening and testing records of Subpart C held as controlled records with their approvals, and the donor and HCT/P identifiers carried as fields on every event

Standards that apply alongside 21 CFR Part 1271

Pharma manufacturingcGMP (21 CFR 210 and 211): The FDA's good manufacturing practice regulations, which apply with Part 1271 when an HCT/P is also regulated as a biologic or a drug
Electronic records21 CFR Part 11: The FDA's rule for the electronic records and signatures the donor eligibility, processing and distribution records will be kept in
Medical devicesISO 13485: The quality management system standard for an HCT/P regulated as a device, where the FDA inspects against the QMSR beside the tissue rules
Pharma manufacturingICH Q10: The pharmaceutical quality system model the FDA reads a biologic manufacturer's quality system through, for a cell or gene therapy made under a BLA

VitaCyte

VitaCyte has found a powerful and adaptable quality management system in Qualio, which enables their team to accelerate their R&D efforts with confidence.

Read the VitaCyte story

“Qualio simplified things immensely.”

Andrew BreiteDirector of Quality Assurance, VitaCyte

Questions about 21 CFR Part 1271

What is 21 CFR Part 1271?

21 CFR Part 1271 is the FDA's regulation for human cells, tissues and cellular and tissue-based products, HCT/Ps, and the establishments that recover, process, store and distribute them. It requires registration and listing, a donor eligibility determination for each donor and current good tissue practice, and the FDA inspects for it and does not certify.

What is a 361 HCT/P?

An HCT/P regulated solely under section 361 of the Public Health Service Act. It must be minimally manipulated, for homologous use, not combined with another article beyond water, crystalloids or a preserving agent, and either have no systemic effect or dependence on living cells, or be for autologous, close-relative or reproductive use. Anything else is a biologic, drug or device.

What does donor eligibility under Part 1271 require?

Subpart C requires a determination, by a responsible person, that each donor is eligible, based on screening of the medical and social history and testing for the relevant communicable disease agents. The HCT/P stays in quarantine until the determination is made, and a summary of the records travels with it to the consignee. Exceptions cover autologous and some reproductive use.

Is there a Part 1271 certification?

No. The FDA does not certify or accredit tissue establishments, and no certification body does. Compliance is shown to an FDA investigator at inspection, on the records the establishment keeps, with observations on a Form 483. AATB accreditation is a separate, voluntary inspection by the association against its own standards, and some states license tissue banks.

Can we add 21 CFR Part 1271 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against every section, beside cGMP or the AATB Standards if you run those too. Sections the frameworks share count once, and the first assessment lists what is covered and what is new.

Is the donor eligibility file still a binder?

Bring it, with your current procedures. We will show you Part 1271 assessed against them subpart by subpart, with the gaps listed and the evidence exported the way an investigator asks.

Book a demo Get started

Less time on audit prep. More time on quality.