FDA updates recommendations for human cell or tissue-based products

April 6, 2020

The Food and Drug Administration (FDA) does not recommend testing asymptomatic donors of human, cells, tissues or other cellular or tissue-based product (HCT/P) for COVID-19, the agency said in a press release.

Noting that routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors, the agency said that SARS-CoV-2 has only been detected in blood samples of a small percentage of severely ill patients. 

The agency also said it is aware that some HCT/P establishments in the United States are considering additional donor screening and testing measures in response to the COVID-19 outbreak. 

The FDA said an HCT/P establishment should evaluate whether a donor in the 28 days prior to the HCT/P procedure: 

•             Cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or

•             Been diagnosed with or suspected of having a COVID-19 infection. 

“While respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps), the potential for transmission of COVID-19 by HCT/Ps is unknown at this time. There have been no reported cases of transmission of COVID-19 via these products,” the FDA said. 

FDA said it will continue to monitor the situation and will issue updates as information becomes available. 

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