Coronavirus: FDA's Advice for the Donation of Cells, Tissue and Products Based on Them

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

The FDA is working closely with the CDC and other federal and international authorities concerning coronavirus to monitor the evolving outbreak of the new type of coronavirus (COVID-19) first identified in Wuhan, Hubei Province, China.

Although so far no transmission of respiratory viruses by implantation, transplantation, infusion, or transmission of human cells, tissues, or cell- or tissue-based products (HCT/Ps) is known or expected, the potential for transmission of COVID-19 by HCT/Ps is currently unexamined and cannot be completely excluded. Up to now, however, no cases of COVID-19 transmission via HCT/Ps have been reported. However, there are already routine screening measures to evaluate clinical evidence of infection in HCT/Ps donors.

The FDA indicates that there is awareness that some HCT/P facilities in the USA are considering additional donor screening measures in response to the COVID-19 outbreak. As long as there is only limited knowledge and information about actual risks, those responsible for evaluating a donor may wish to consult and consider the following historical information (within the last 28 days):

• Has the donor travelled to areas with COVID-19 outbreaks as defined by the CDC? 
• Has he or she lived with persons who have been diagnosed or suspected of having COVID-19 infection? or
• Has he or she been diagnosed or suspected of having COVID-19 infection?

More details and follow-up updates on the coronavirus and measures can be found on the FDA website.