FDA Classification/Reclassification of Immunohistochemistry Reagents: Practical Considerations

AbstractThe Food and Drug Administration (FDA) is responsible for regulating the manufacture of in vitro diagnostic reagents. The level of regulation is linked to the level of risk posed by the product. Recently, the FDA published a proposed rule concerning the regulation of immunohistochemistry (IHC) reagents. The proposed rule states, in part, that the degree of risk to the patient associated with the use of IHC products depends on whether the product is used as an adjunct to conventional histopathology diagnostic techniques or provides information that is used independent of the conventional diagnostic process. The ruling makes no distinction on the basis of demonstrated use in basic research or clinical laboratory medicine. Under the proposed rule, manufacturers of IHC reagents would be required to submit a minimum of a premarket notification for each reagent. The premarket notification, or 510(k), imposes a time consuming and expensive regulatory hurdle. For purposes of comparison, biological stains ...