The U.S. Food and Drug Administration (FDA) issued a communication on August 29th titled “Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation.” In the communication, the agency stated that “[w]orldwide, there have been no reports of transmission of monkeypox virus through use of human cells, tissues, or cellular or tissue-based products (HCT/Ps); therefore, the risk of infection transmitted by implantation, transplantation, infusion, or transfer of HCT/Ps remains theoretical. Monkeypox virus nucleic acid has been detected in tissues and secretions of infected humans, such as in skin, semen, and placenta; however, the levels of infectious virus in human cells and tissues have not been well characterized. Routine screening measures, for the purposes of making a donor eligibility determination, are already in place for evaluating risk factors and conditions as well as clinical evidence and physical evidence of infection in HCT/P donors.”
The FDA added that it “does not recommend using laboratory diagnostic tests to screen HCT/P donors for monkeypox virus. The HCT/P establishment’s responsible person (21 CFR 1271.3(t)) must determine and document the eligibility of a cell or tissue donor (21 CFR 1271.50).