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.
Establishments that manufacture HCT/Ps — recover, process, store, label, package, or distribute human cells and tissues.
- 01Register the establishment and list HCT/Ps
- 02Determine donor eligibility through screening and testing
- 03Apply Current Good Tissue Practice to prevent contamination and cross-contamination
- 04Maintain records enabling tracking from donor to recipient
The CGTP requirements became effective in 2005, consolidating tissue safety under a single framework; periodically updated as testing expectations evolve.
21 CFR Part 1271: frequently asked questions
Quick answers to common questions about 21 CFR Part 1271.
What is 21 CFR Part 1271?
21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) — is a regulation issued by the Food and Drug Administration (United States). 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.
Who does 21 CFR Part 1271 apply to?
Establishments that manufacture HCT/Ps — recover, process, store, label, package, or distribute human cells and tissues.
What are the key requirements of 21 CFR Part 1271?
FDA 21 CFR Part 1271 requires, among other things: 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.
When was 21 CFR Part 1271 last updated?
The current version of 21 CFR Part 1271 dates from May 2005. The CGTP requirements became effective in 2005, consolidating tissue safety under a single framework; periodically updated as testing expectations evolve.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 1271 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.