AATB and FDA standards, explained
Two different bodies, two different jobs — and together, the framework every tissue bank we work with has to meet.
Last updated: July 2026
The American Association of Tissue Banks (AATB) is a nonprofit founded in 1976. Its Standards for Tissue Banking, first published in 1984, are the only private tissue banking standards in the United States and among the most comprehensive in the world — detailed enough that they’ve served as a model for federal regulation and international directives. AATB accreditation means a tissue bank has passed a comprehensive inspection verifying it operates to those standards, from donor eligibility through final release.
The FDA, by contrast, is the federal regulator. Under 21 CFR Part 1271, it sets the legal requirements for handling human cells, tissues, and cellular and tissue-based products (HCT/Ps) — donor eligibility screening and testing, manufacturing controls, and labeling. Meeting AATB Standards and complying with FDA regulation aren’t the same thing, but in practice a well-run tissue bank is built to satisfy both.
We work with tissue bank partners held to both bars. It’s the reason we can stand behind the traceability and documentation on everything we distribute.
Sources
AATB — Standards for Tissue Banking · AATB — Accreditation · eCFR 21 CFR Part 1271