Code of Federal Regulations (CFR) Title 21 Part 607 discusses establishment registration. Facilities that manufacture blood components must register with the FDA and provide a listing of all manufactured blood products. Registration is required annually between October 1 and December 31, and the product listing information must be updated every June and December.
2An exemption is made for transfusion services that perform compatibility testing and transfusion of blood and blood components but do not routinely collect or process blood and blood components. The exempt transfusion service must be part of a facility certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or meet equivalent requirements determined by the Centers for Medicare and Medicaid Services (CMS). Note that the collection and processing of blood and blood components in an emergency (determined by a responsible person and documented in writing), therapeutic collection of blood or plasma, preparation of recovered human plasma for further manufacturing use, or preparation of red blood cells for transfusion are not acts requiring establishment registration.
