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Regulatory

AABB

AABB, formerly the American Association of Blood Banks, is a standards and accreditation organization with roots in blood banking and transfusion medicine. Some HCT/P processors describe elements of their work as following AABB guidelines.

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

As with AATB, a claim of following AABB guidelines describes a company's own stated practice rather than an FDA license or registration. It is a distinct claim from formal AABB accreditation, and the two should not be assumed to mean the same thing when reading vendor materials.

A buyer evaluating this claim can ask a vendor to identify the specific AABB-aligned step being referenced, such as a serology testing panel or quarantine-and-release process, and request the documentation that demonstrates it, such as lot-specific testing records, rather than accepting the organization's name as a credential on its own.

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.

Knowing what AABB guidelines actually cover helps a buyer ask precise follow-up questions instead of treating the acronym as a stand-alone assurance.

Sources

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