...
Blood products can include blood, red blood cells, fresh/frozen plasma, platelets, plasma derivatives, albumen, immune globulins, clotting factor concentrates, things that are made by recombinant DNA technology, reagents that test for infectious disease or are used to type the blood, and even the blood bank software used to keep track of the donations. All of these were regulated by the National Institutes of Health (NIH) Division of Biologics Standards (DBS) and later the Center for Biologics Evaluation and Research (CBER) when they were transferred to the Food and Drug Administration (FDA). As medical devices (regardless of when they were used) the syringes featured below would have been regulated by FDA under the 1938 Food, Drug, and Cosmetic Act.
Court Cases
In 1962, the DBS brought suit against John P. Calise and the Westchester Blood Bank for intentionally altering the expiration dates on whole blood so that the product dating would exceed the 21-day requirement. He pleaded guilty and was convicted in 1963 on three counts of misbranding, three counts of false labeling, two counts of shipping an unlicensed biological product, and one count of conspiracy. Calise was placed on probation for five years and forbidden to engage in the manufacture, distribution, or sale of any biological, plasma, or blood products. The case marked the first court confirmation that blood is a drug under the definition of the Food, Drug, and Cosmetic Act. The case also marked the first litigation brought against a biologics manufacturer.
...
Overview
Content Tools
ThemeBuilder