UC知道帮忙翻译一句话,谢谢啦
来源：百度知道 编辑：UC知道 时间：2024/06/01 10:15:17
We have reviewed your Section 510(k) pre-market notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate device in interstate commerce prior to May 28,1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a pre-market approval application (PMA). You may, therefore market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
我们检讨了你第510(k)项售前意向通知该装置市场的决心,并参照上述 耗电大幅度同等学历(适应症使用于附文)为合法销售始发州际装置 前五月28,1976商贸、颁布日期的医疗器械修正案 器件或已归类依照<联邦食品、药品、 美容法(法)不需要批准了售前核准申请(物业管理). 你可能因此市场器件,受到普遍的管制法令的规定. 一般管制法令的规定,包括需要登记年度,上市装置,优良制造规范、标识、 掺假、禁止.
我们回顾意向的您的部分510(k) 前市场通知销售设备参考以上并且确定了设备与被重新列级了与不要求前市场认同应用的认同联邦食物、药物, 和化妆法案符合的设备是极大地等效的(为征兆至于使用陈述在封入物) 与法律上被销售的谓语设备在州际贸易在日期之前5月28,1976 日, 医疗设备校正的制定, 或(法案的) 的供应(PMA) 。您可以, 因此销售设备, 依于法案的将军控制供应。行动的将军控制供应包括每年注册, 列出设备, 好制造业实践, 标记, 和禁止的要求反对misbranding 和冒牌。
这句话还真是短啊...