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:
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.”
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