FDA updates information for human cell, tissue, or cellular or tissue-based product (HCT/P) establishments regarding COVID-19 pandemic

April 3, 2020

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, states the Food and Drug Administration (FDA).

There have been no reported cases of transmission of COVID-19 via these products. Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors.

The FDA is aware that some HCT/P establishments in the U.S. are considering additional donor screening and testing measures in response to the COVID-19 outbreak. At this time, the FDA does not recommend establishments use laboratory tests to screen asymptomatic HCT/P donors. Based on available information, it appears that SARS-CoV2 has only been detected in blood samples of a small percentage of severely ill patients.

The HCT/P establishment’s responsible person must evaluate a prospective donor and determine eligibility (21 CFR 1271.50). Based on the limited information available at this time, establishments may wish to consider, whether, in the 28 days prior to HCT/P recovery, the donor 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 COVID-19 infection.

For HCT/Ps regulated as biological products under Section 351 of the Public Health Service Act, FDA is continually assessing available scientific evidence, and evaluating benefits and risks, to determine whether SARS-CoV-2 testing is warranted on certain types of HCT/Ps used in the manufacture of a biological product and/or warranted for the final product.

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

FDA has the statement.

More COVID-19 coverage HERE.