Human Cells and Tissues: Part 1271 and Tissue Practices

The definition concerns human cells or tissues intended for implantation, transplantation, infusion or transfer into a human recipient, with specified exclusions. Vascularized organ transplantation is not simply another tissue-establishment category. The source material, processing, final composition and intended clinical use must be described before deciding which provisions govern the operation. FDA tissue explanation.

Section 1271.10 sets criteria that must be met for an HCT/P to be regulated solely under section 361 and Part 1271. Minimal manipulation and homologous use are separate criteria; other criteria also matter. Autologous use or a tissue-related name alone does not establish eligibility. Products outside that pathway can raise drug, biologic or device requirements. Part 1271.

FDA’s final guidance discusses minimal manipulation and homologous use through the characteristics of the original tissue and the product’s intended function in the recipient. Claims made in labeling and promotion are relevant to intended use. Its examples aid interpretation; they do not grant authorization to an unrelated product described with similar terminology. FDA final guidance.

Donor screening and testing reduce communicable-disease risks where required. Current good tissue practice addresses facilities, environmental controls, equipment, supplies, processing and storage, among other matters. Applicability and exceptions differ between provisions. A donor test result cannot substitute for the processing and traceability controls that protect the resulting HCT/P throughout manufacture and distribution. FDA tissue requirements.

Required records support donor eligibility determinations, processing history and the ability to track relevant tissue. Deviations, complaints and reporting duties must be assessed under the applicable provisions. Registration and listing identify establishments and products; they do not approve treatment claims or prove that all section 361 criteria are satisfied. Regulatory text.

Document identity, processing and intended use; evaluate every relevant criterion and exception; then identify the resulting registration, practice and premarket requirements. The guidance’s historical enforcement-discretion period ended in 2021 and must not be presented as current protection. Read the present obligations alongside the product-specific facts and any FDA correspondence. Guidance and historical period.