We, the Center for Biologics Evaluation and Research (CBER)1 at the FDA, are issuing this guidance to provide you, tissue establishments and healthcare professionals, with our current thinking on the scope of the exception set forth in Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the exception set forth in 21 CFR 1271.15(b). This guidance does not address the other exceptions in 21 CFR 1271.15.  This guidance, presented in question and answer format, provides our current interpretation of this regulation and includes examples based on inquiries received by the Agency since the final rule, “Human Cells, Tissues, and Cellular and Tissue Based Products; Establishment Registration and Listing” (Establishment Registration and Listing final rule) was published on January 19, 2001 (66 FR 5447).

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