FDA Releases Suggestions for Evaluating Donors for Coronavirus
The United States Food and Drug Administration (FDA) published Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak on February 14, 2020. This announcement notes that the FDA has been working closely with the Center for Disease Control (CDC) and other federal and international agencies to monitor the outbreak of coronavirus (COVID-19).
The FDA stated that respiratory viruses are not generally known to be transmitted by HCT/Ps, potential for coronavirus transmission via these products is unknown. Although routine screening measures for infections are already in use, some programs may wish to use additional donor screening in response to this outbreak. Based on limited information available, the FDA says programs may wish to consider the donor history in the 28 days prior to cell collection for potential donors who have:
- traveled to areas with COVID-19 outbreaks, as defined by CDC
- lived with individuals diagnosed with or suspected of having COVID-19 infection; or
- been diagnosed with or suspected of having COVID-19 infection.
The following are additional details provided by FDA:
