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FDA Updated Information on HCT/Ps for COVID-19 Pandemic

Bulletin 21-1

January 7, 2021

On January 5, the FDA notified the American Association of Tissue Banks (AATB) about its Safety and Availability Communication posted to the FDA website on January 4, 2021, titled “Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic”. 
The highlights of this updated communication are as follows:
  • FDA continues to work closely with CDC and other federal and international agencies to monitor the coronavirus disease 2019 (COVID-19) pandemic caused by the virus, SARS-CoV-2. 
  • 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.
  • FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors.
  • 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 pandemic.
  • The HCT/P establishment’s responsible person must determine and document the eligibility of a cell or tissue donor (21 CFR 1271.50). Based on 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
    • 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.
  • COVID-19 vaccines are complex biological products intended to be administered to millions of individuals to prevent COVID-19. Recently, vaccines for the prevention of COVID-19 have become available under emergency use authorization (EUA) issued by the FDA.  
  • Based on information available at this time, those who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps.
This information can also be reached from:
In addition, the FDA informed AATB about Proposed rule titled “Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater”, published on 12/21/2020:
  • https://www.federalregister.gov/documents/2020/12/21/2020-27828/revocation-of-the-regulations-for-human-tissue-intended-for-transplantation-and-human-dura-mater  
  • As explained in the proposed rule, FDA proposes to revoke the regulations under part 1270 (21 CFR part 1270), “Human Tissue Intended for Transplantation” and § 882.5975 (21 CFR 882.5975), “Human dura mater.” These regulations apply to certain tissues recovered prior to May 25, 2005 as defined in §1270.3(j). The Agency does not believe there are currently any of these tissues intended for transplantation remaining in inventory that were recovered prior to this date and that would be subject to these regulations. The proposed revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005.  The public comment period ends on March 8, 2021.  
 
If you have any questions, please contact Dr. Roman Hitchev, AATB Vice President and Chief Science Officer at hitchevr@aatb.org