Fed Regist. 2014 Jun 2;79(105):31205-14.
The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
美国食品药品监督管理局（FDA或该机构）正在将用于使皮肤晒黑的紫外线（UV）灯从免于上市前通知的I类（一般控制）重新分类为II类（特殊控制）并需进行上市前通知，并将其重新命名为太阳灯产品以及用于太阳灯产品的紫外线灯。FDA正在指定必要的特殊控制措施，以合理确保该设备的安全性和有效性。FDA基于新信息自行对该设备进行重新分类。
