Final Rule

Every so often, the U.S. FDA comes out with a new set of requirements for a particular aspect of blood collection and/or processing. These requirements are entered into the Code of Federal Regulations (CFR), and become federal law (FDA does not do this very often, instead choosing to update things with FDA Guidances, which are not really “law” per se, but function as industry standards). In May 2015, the FDA issued the final version of a rule that they originally released for comment in 2007, known as “Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use.” In our industry, we call this the “Final Rule.” All U.S. blood collection centers have had to upgrade and/or change processes to adapt to the changes in the Final Rule, including the new variation between acceptable male and female hemoglobin levels in donors. See my blog post on the Final Rule for more.

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