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Regulatory

AATB

AATB, the American Association of Tissue Banks, is a nonprofit standards-setting and accreditation organization for tissue banking. Some HCT/P processors describe their recovery and processing practices as following AATB guidelines.

Processing is described as following FDA regulations and AATB and AABB guidelines. Request supporting documentation rather than infer certification from that description alone.

Describing a process as "following AATB guidelines" is a statement about a company's own internal practice, not an FDA registration, license, or government endorsement. It is also a different claim from being formally AATB-accredited, and a buyer should ask a vendor which specific claim applies to its operation.

A useful next step is asking which specific AATB-aligned practices apply to a given lot, such as donor medical and social history review, serology testing, and recovery timelines, and requesting supporting documentation such as the certificate of analysis and donor eligibility summary, rather than treating the phrase "AATB guidelines" alone as sufficient evidence.

These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.

AATB guideline claims describe a vendor's self-reported practice standard, so a buyer should request the documentation behind the claim rather than relying on the phrase itself.

Sources

  1. 21 CFR 1271.10 - Are my HCT/Ps regulated solely under section 361 of the PHS Act ↗eCFR