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predicate device

Chinese translation: 对比器械/比较产品

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:predicate device
Chinese translation:对比器械/比较产品
Entered by: Edward LIU
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17:31 Feb 12, 2005
English to Chinese translations [PRO]
Medical: Health Care
English term or phrase: predicate device
if the device does not have a predicate device.....
Xiedong Lei
China
Local time: 10:18
对比器械/比较产品
Explanation:
510(k)文件是向FDA递交的上市前申请文件,目的是证明申请上市的器械与不受上市前批准(PMA)影响的合法上市器械同样安全有效,即为等价器械(substantially equivalent)。申请者必须把申请上市的器械与现在美国市场上一种或多种相似器械对比,得出并且支持等价器械的结论。合法上市器械是在1976年5月28日之前合法上市的器械(preamendment device),或者从III类器械中分入II或I类的器械,或者通过510(k)程序发现与这样的器械等价的器械,或者通过自动的III 类器械定义的评价建立的器械。与之等价的器械被称为“predicate device(s)”。 申请者必须提交描述性的数据,必要的时候,要提交性能数据来说明器械是predicate device的等价器械。再次说明,510(k)的数据是显示相似性的数据,即,新器械与predicate device的等价程度。
http://www.china-pharm.com/510(k)1.htm
Selected response from:

Edward LIU
Local time: 22:18
Grading comment
Thanks
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +2依据性设备/产品/器材
XiaoRan
4参照器械thaliagz
4建议
Lu Zou
3对比器械/比较产品
Edward LIU


  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
对比器械/比较产品


Explanation:
510(k)文件是向FDA递交的上市前申请文件,目的是证明申请上市的器械与不受上市前批准(PMA)影响的合法上市器械同样安全有效,即为等价器械(substantially equivalent)。申请者必须把申请上市的器械与现在美国市场上一种或多种相似器械对比,得出并且支持等价器械的结论。合法上市器械是在1976年5月28日之前合法上市的器械(preamendment device),或者从III类器械中分入II或I类的器械,或者通过510(k)程序发现与这样的器械等价的器械,或者通过自动的III 类器械定义的评价建立的器械。与之等价的器械被称为“predicate device(s)”。 申请者必须提交描述性的数据,必要的时候,要提交性能数据来说明器械是predicate device的等价器械。再次说明,510(k)的数据是显示相似性的数据,即,新器械与predicate device的等价程度。
http://www.china-pharm.com/510(k)1.htm


Edward LIU
Local time: 22:18
Works in field
Native speaker of: Native in ChineseChinese
PRO pts in category: 65
Grading comment
Thanks
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4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
依据性设备/产品/器材


Explanation:
predicate device 的含义是用于评价新设备/产品的、作为评价依据的已上市的旧有设备/产品。
predicate device 似乎还没有现成的译法,根据predicate词意及predicate device 含义,建议译为依据性设备/产品/器材

XiaoRan
Local time: 10:18
Works in field
Native speaker of: Native in ChineseChinese
PRO pts in category: 47

Peer comments on this answer (and responses from the answerer)
agree  Xiang Ding
1 day6 hrs
  -> thanks.

agree  David Li
3 days21 hrs
  -> thanks.
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1 day4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
建议


Explanation:
同意以上两位的意见,不知叫等效可比产品是否恰当,因为predicate device首先要有等效(等效性),然后在其他几个方面有可比性。


    Reference: http://www.fda.gov/cdrh/devadvice/31432.html
    Reference: http://www.zmdcc.com/fda/fda_04.asp
Lu Zou
Australia
Local time: 12:18
Specializes in field
Native speaker of: Native in ChineseChinese
PRO pts in category: 178
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3529 days   confidence: Answerer confidence 4/5Answerer confidence 4/5
参照器械


Explanation:
我觉得理解为参照物也未尝不可,请各位矫正。

thaliagz
China
Local time: 10:18
Native speaker of: Native in ChineseChinese
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