REGULATORY UPDATE: FDA Updates Safety Communication for HCT/Ps

January 06, 2021

The Food and Drug Administration posted updated information for human cell, tissue, or cellular or tissue-based product (HCT/P) establishments regarding the COVID-19 pandemic on the Safety and Availability Communication web page. The agency confirmed that:

  • 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). 
  • To date, 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.

While FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors, the agency noted that some HCT/P establishments in the U.S. are considering additional donor screening and testing measures in response to the COVID-19 pandemic. Current donor eligibility regulations at 21 CFR 1271.50  state that a responsible person, as defined in section 1271.3(t), must determine and document the eligibility of a cell or tissue donor.

FDA has not issued HCT/P donor screening recommendations. However, similar to the early approach for optional screening of blood donors, FDA provided the following information for establishments considering optional, voluntary actions:  

“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 had been diagnosed with or suspected of having COVID-19 infection; or had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms.”

With respect to HCT/P donation following COVID-19 vaccination, FDA confirmed that “those who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps.” 

Please send your questions and concerns to regulatory@aabb.org.