Blood-Grouping Reagents

Most blood-grouping reagents require either 510(k) clearance or premarket approval (PMA) from FDA CBER before they can be legally marketed in the US. The specific pathway depends on the reagent's risk classification and whether a predicate device exists. Importers should confirm that the foreign manufacturer holds the appropriate FDA marketing authorization for each specific reagent product before shipment.

FDA's Center for Biologics Evaluation and Research (CBER) retains regulatory authority over blood and blood-related products, including in vitro diagnostics used in blood banking and transfusion medicine. This is a historical jurisdictional carve-out: even though blood-grouping reagents function as devices, their direct connection to blood safety keeps them under CBER rather than the Center for Devices and Radiological Health (CDRH).