Are some ASRs Class II or Class III, requiring a premarket submission?
Yes. Although most ASRs are Class I, there are some ASRs that are Class II and Class III and that must be cleared or approved by FDA before they can be marketed in the United States. 21 CFR 864.4020. FDA classifies medical devices, including diagnostic devices such as ASRs, into Class I, II, or III according to the level of regulatory control that is necessary to provide a reasonable assurance of safety and effectiveness. These classifications include consideration of the level of risk associated with the device. 21 U.S.C. 360c. The classification of an ASR determines the appropriate premarket process. An ASR is a Class II device if the reagent is used as a component in a blood banking test of a type that has been classified as a Class II device (e.g., certain cytomegalovirus serological and treponema pallidum nontreponemal test reagents). 21 CFR 864.4020(b)(2).
