Fed Regist. 1998 Nov 3;63(212):59222-31.
The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).
美国食品药品监督管理局（FDA）正在将1998年1月21日《联邦公报》通知中列为豁免的所有62种II类（特殊控制）设备免于上市前通知的规定进行编纂，但需符合豁免限制。FDA已确定，对于这些豁免设备，制造商提交上市前通知对于确保安全性和有效性并非必要。这些设备仍将受现行良好生产规范（CGMP）法规及其他一般控制措施的约束。本规则制定实施了《食品药品管理局现代化法案》（FDAMA）授予FDA的新权力。
