Food and Drug Administration

Previously, the Food and Drug Administration played a very little role in the regulation of the cord blood bank industry. Although the FDA had established guidelines, which many cord blood banks voluntarily followed, the only regulations the FDA placed on the industry was mandatory screening for various diseases, including HIV.

Since the beginning of 2004, the FDA has begun to take steps towards regulating the industry. By January 2004, all cord blood banks needed to register with the FDA in order to allow for easier tracking of the companies and the stem cells that the banks are storing. By May of the same year, banks were required to screen both the mother and the baby's blood for infectious diseases, which most banks were already doing.

Starting in May 2005, the FDA requires that all banks which handle human cells and tissue follow the federal safety standards as set out by the FDA. These regulations outline specific steps banks and laboratories must take when they are processing the cord blood. These regulations apply to the collection, processing, packaging, labeling and distribution of the cells. Additionally, under this new regulation, cord blood banks must notify the FDA of specific adverse reactions in the stem cells that they process and to allow for FDA inspections.


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