Fed Regist. 1998 Jun 3;63(106):30132-42.
The Food and Drug Administration (FDA) is issuing a final rule to classify/reclassify immunohistochemistry reagents and kits (IHC's) into three classes depending on intended use. FDA is classifying/reclassifying into class I (general controls) and exempt from premarket notification requirements IHC's used as adjunctive tests and presenting a low risk to public health. FDA is classifying/reclassifying into class II (special control) IHC's that detect or measure certain target analytes and that provide prognostic or predictive data that is not confirmed by routine histopathologic control specimens. The results of the class II IHC's are reported independently to the clinician, and the performance claims are widely accepted and supported by valid scientific evidence. FDA is classifying/reclassifying into class III (premarket approval) IHC's intended for any other use. The scope of products covered by this final rule includes both pre-1976 devices that have not been previously classified, as well as post-1976 devices that are statutorily classified into class III. The intent of this final rule is to regulate pre-1976 devices and post-1976 devices in a consistent fashion. Therefore, FDA is classifying or reclassifying these products as applicable.
美国食品药品监督管理局（FDA）正在发布一项最终规则，根据预期用途将免疫组织化学试剂和试剂盒（IHC）分为三类。FDA正在将用作辅助检测且对公众健康风险较低的IHC归类为I类（一般控制）并豁免上市前通知要求。FDA正在将检测或测量某些目标分析物并提供未经常规组织病理学对照标本证实的预后或预测数据的IHC归类为II类（特殊控制）。II类IHC的结果会独立报告给临床医生，其性能声明得到广泛认可并有有效的科学证据支持。FDA正在将用于任何其他用途的IHC归类为III类（上市前批准）。本最终规则涵盖的产品范围包括1976年以前未分类的器械以及法定归类为III类的1976年以后的器械。本最终规则的目的是以一致的方式对1976年以前和1976年以后的器械进行监管。因此，FDA将视情况对这些产品进行分类或重新分类。
