Standards & Policies

FDA Federal Register:

Requirements For Blood And Blood Components Intended For Transfusion Or Further Manufacturing Use*

An updated version of the Federal Register – Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Final Rule, 21 CFR Parts 606, 610, 630, et al. was issued in May 2015 with an effective date of May 23, 2016.

One of the purposes of this updated Final Rule is to assure the safety, purity, and potency of the blood and blood component products used for transfusion and for further manufacture.

The risk of septic transfusion reaction is well understood by the FDA. Section 606.145 of the Federal Register Final Rule states that both blood collection establishments and transfusion services must assure that the risk of bacterial contamination of platelets is adequately controlled using FDA approved or cleared devices or other adequate and appropriate methods found acceptable for this purpose by FDA.