Fed Regist. 1997 Nov 21;62(225):62243-60.
The Food and Drug Administration (FDA) is issuing a final rule to classify/reclassify analyte specific reagents (ASR's) presenting a low risk to public health into class I (general controls), and to exempt these class I devices from the premarket notification (510(k)) requirements. FDA is classifying/reclassifying ASR's used in certain blood banking tests as class II (special controls) because general controls are insufficient to provide a reasonable assurance of safety and effectiveness. Finally, ASR's presenting a high risk are being classified or retained in class III (premarket approval). FDA is also designating all ASR's as restricted devices under the Federal Food, Drug and Cosmetic Act (the act), and establishing restrictions on their sale, distribution and use. The scope of products covered by this final rule includes both pre- 1976 devices, which have not been previously classified, as well as post- 1976 devices, which are statutorily classified into class III. The intent of this final rule is to regulate these pre- and post-1976 devices in a consistent fashion. This rulemaking does not affect requirements for reagents that are subject to licensure under the Public Health Service Act (the PHS Act). This rulemaking also does not affect reagents sold to nonclinical settings, including those reagents sold as components to manufacturers of cleared or approved in vitro diagnostic tests.
美国食品药品监督管理局（FDA）正在发布一项最终规则，将对公众健康风险较低的分析物特异性试剂（ASR）归类/重新归类为I类（一般控制），并使这些I类器械免于上市前通知（510(k)）要求。FDA将某些血库检测中使用的ASR归类/重新归类为II类（特殊控制），因为一般控制不足以合理保证其安全性和有效性。最后，对公众健康风险较高的ASR将被归类或保留在III类（上市前批准）。FDA还将所有ASR指定为《联邦食品、药品和化妆品法案》（该法案）下的受限器械，并对其销售、分销和使用进行限制。本最终规则涵盖的产品范围包括1976年之前未进行过分类的器械，以及根据法律归类为III类的1976年之后的器械。本最终规则的目的是以一致的方式对这些1976年之前和之后的器械进行监管。本规则制定不影响根据《公共卫生服务法案》（PHS法案）需获得许可的试剂的要求。本规则制定也不影响销售给非临床环境的试剂，包括作为已获批或已批准的体外诊断测试制造商组件销售的那些试剂。
