12/13 March 2024
The FDA clearly requires in its guidelines that donors of cells, tissues, and cellular or tissue-based products must be tested for relevant pathogens and diseases (Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Specific Requirements). For that purpose tests licensed, approved or cleared by the FDA must be used. For example, for all donors, this applies to tests for
In certain cases, moreover, the tests for
Since this affects a wide variety of pathogens or diseases and also a very heterogeneous group of products of biological origin, the FDA provides an overview on their page "Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases":
On the same page you can also find the links to the related relevant pages about the topics
In addition, the page also links to more detailed information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable pathogens and diseases under § 1271.80.
To find more detailed information please visit the FDA website at "Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases".