We, the Center for Biologics Evaluation and Research (CBER) 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).

This guidance finalizes the draft guidance of the same title dated October 2014. This guidance also finalizes certain material related to adipose tissue that was included in the draft guidance entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” dated December 2014 (Adipose Draft Guidance). These material, together with the material related to adipose tissue included in the final guidance entitled “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff” dated November 2017, supersedes the Adipose Draft Guidance. Accordingly, we do not intend to finalize the Adipose Draft Guidance which is now withdrawn.

Posted on the FDA website on 16 November 2017