Human Tissue Intended for Transplantation

The information collection requirements help prevent the transmission of communicable diseases through human tissue transplantation by requiring that written SOPs be prepared and followed for the following: (1) infectious disease testing; (2) determining the medical history of the donor; (3) designating and identifying quarantined tissue; and (4) preventing infectious disease contamination or cross-contamination of tissue during processing. The regulations require maintenance of records of all significant steps in the infectious disease testing, and screening, and require that these records be made available for FDA inspection. Adequate donor screening and testing must be recorded so that the suitability of the tissue can be determined. If FDA is unable to ascertain how a tissue donor was screened or tested, or if the tissue was distributed in violation of the regulations, then recall, retention, and/or destruction orders may be issued by FDA in accordance with codified administrative procedures.

The latest form for Human Tissue Intended for Transplantation expires 2023-02-28 and can be found here.

Human Tissue Intended for Transplantation

Federal Enterprise Architecture: Health - Consumer Health and Safety