英语翻译Before submitting the 510(k) for review,the following should be considered:General Formatting Information请把下面的翻译成英文,（太长了不好意思）A 510(k) may be formatted in sections,with page numbering,to contain a numb

英语翻译Before submitting the 510(k) for review,the following should be considered:General Formatting Information请把下面的翻译成英文,（太长了不好意思）A 510(k) may be formatted in sections,with page numbering,to contain a numb
英语翻译
Before submitting the 510(k) for review,the following should be considered:
General Formatting Information
请把下面的翻译成英文,（太长了不好意思）
A 510(k) may be formatted in sections,with page numbering,to contain a number of required elements including:
-a Cover Sheet or Cover Letter,
-a Table of Contents,
-a description of the device,
-information on device specifications,
-labeling,
-testing data when required,
-a comparison with a predicate device(s),and,if applicable,information on sterilization,
-computerized aspects,
-standards to which the device adheres,
-manufacturing information,
-paper size should be 8.5 inches by 11 inches,
paper should be 3-hole punched on the LEFT side,
the margin on left should be 1.5 inches.
Assembling a 510(k)
A 510(k) should be put in a temporary binder.Upon receipt FDA or a third review party will take the application out of the binding in which it was submitted,3-hole punch the left margin,and put the 510(k) in a 3-ring "jacket" for review.
It is important to have all pages numbered correctly and DO NOT permanently bind the application.If pages are removed by FDA during the review process,to be copied for example,this will help the reviewer put the pages back in the correct order.
Three copies of the 510(k) should be submitted to a third party,and the applicant should retain an additional copy.Two copies are submitted to the FDA and one retained by the third party.
A letter authorizing the third patry (when applicable) to submit the document and discuss the contents of the submission on your behalf must also accompany the submission.
Particular Formatting of a 510(k)
To assist the manufacturer in constructing a 510(k),the FDA has generated many guidance documents.It is important that you check the databases for the existence of a guidance document.
去哪领奖？要不要先交钱在领奖？

英语翻译Before submitting the 510(k) for review,the following should be considered:General Formatting Information请把下面的翻译成英文,（太长了不好意思）A 510(k) may be formatted in sections,with page numbering,to contain a numb
晕死!机器翻译还有什么不明白的?不明白继续翻啊,翻到明白不就得了?

一个510(k)格式可能在部分,页码编号、含有一定数量的必需元素,包括:

-封面页或封面信,
(表的内容,
描述的装置,-
在设备规格、-information
-labeling,
当需要时,-testing数据,
用一个谓词装置——比较(s),而且,如果适用的话,信息在杀菌,
-com...

全部展开

一个510(k)格式可能在部分,页码编号、含有一定数量的必需元素,包括:

-封面页或封面信,
(表的内容,
描述的装置,-
在设备规格、-information
-labeling,
当需要时,-testing数据,
用一个谓词装置——比较(s),而且,如果适用的话,信息在杀菌,
-computerized方面,
对设备以-standards,
-manufacturing信息,
8.5英寸-paper大小应由11英寸,
纸应该3-hole左边,穿孔
在左边边缘应1.5英寸。

安装一个510(k)。

一个510(k)应放在一个临时粘结剂。食品药物管理局(FDA)或三分之一在收到申请审查聚会将从绑定在它被提交,3-hole冲床左边边缘,并把510(k)在一个3-ring夹克的审核。

这是很重要的,并标示页码都没有正确的应用。永远绑如果页面都被FDA在审查过程,来复制为例,这将帮助那些评论员将页面回到正确的顺序。

三份510(k)应提交给第三方,申请人应保留一个额外的副本。两个副本都交给FDA和保留由第三方。

一封批准后方能生效(当适用第三次)提交文件的内容,讨论了代表你也必须提交伴随提交。

特定的格式,一个510(k)

协助生产建设510(k),美国食品及药物管理局已经产生许多指导文件。最重要的是你检查数据库存在的指南。
有些地方不是很明白……所以就用英文替代了

收起