Question

英文信件请帮忙翻下，关于医疗器械方面的

I have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to MAY 28,1976,the enactment date of Medical Device Amendments.You may,therefore,market device.subject to the general controls provisions of the Federal Food ,Drug,and Cosmetic Act(ACT).The general controls provisions of the act include requirements for annual registration.Listingdevices,good manufanturing practice,and labeing.and prohibitions against misbranding and adulteration.

If your decive is classified into either class 2(Performance Standards) or class 3 it may be subject to additional controls.Existing major regulations atfecting your device can be found in the code of federal regulations. Title 21,parts 800 to 895.in addition,the food and durg administration(FDA) may publish further announcements concerning your device in the federal register. Pleasa note: this response to your premarket notification submission does not affect any obligation you might have under the radiation control for health and safety act of 1968,or other federal laws or regulations.
This letter immediately will allow you to begin maketing your device as described. An FDA finding of substantial equivalence of your device to a pre-amendments device results in a classification for your device and and
Permits your device to proceed to the market ,but it does not mean that FDA approved your device .Therefore,you may not promot or in anyway represent your device or its labeling as being approved by FDA.
问题补充：请不要用谷歌翻译等，这个我也会，那个翻译的很不准的。帮我翻译

Answer 1

我看了你的部分510(k)知会意想去市场的装置,我们决定了参考上面所有的设备是大体上相当于设备出现在州际商务之前,1976年5月28日,制定医疗器械修改你可能会因此市场的总体控制规定device.subject联邦食品、药品、化妆品(行为),一般管制法案的规定要求,包括年度注册Listingdevices、良好的manufanturing实践,labeing.and禁止misbranding和叙述。

如果你decive分为两个类别2(性能标准)或第3类可额外控制目前存在的主要设备atfecting规定,可以发现,在美国联邦法规。标题,部分895.in 21名,食物和政府已成立管理局(FDA)公布有关你的设备的进一步声明联邦登记。注:这个反应Pleasa premarket通知您提交的任何义务,不影响你可能已经在辐射控制的健康和安全的行为,或其它联邦1968年法律或法规。
这封信马上就会让你开始制定正确的描述你的装置。一位美国食品药品管理局发现殷实的等价的设备pre-amendments装置,结果为你的设备和分类
允许你的设备进行市场,但这并不意味着食品及药物管理局(FDA)批准你的设备,因此,你不可以促进或在很大程度上代表你的设备或其标签是FDA批准。

Answer 2

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