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Bench test report translation to English for 510(k) submission

#1
Hi, We have a bunch of non-English test reports from a third party who performed the tests. Can the manufacturer themselves translate these documents or should the third party vendor do it or should it be verified and signed by someone? I know FDA wants everything to be in English but do they say anything about who should do the translation?
 
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shimonv

Trusted Information Resource
#2
The FDA does not dictate who should do the translations. I think it would be best if the manufactures will translate the bench test reports and put their name and signature to it. You can do the review and ask questions if needed.
 

Kuldeep Singh

Involved In Discussions
#3
Hi

We Submitted the 510(k) traditional file for Class II X-Ray medical device commonly named as High Frequency C-Arm machine and need to provide additional information as required by FDA inspector. All the required data almost compiled except Dosimetric comparison. They demands for Dosimetric comparison with predicate device. Can anyone share his experience/ suggestions or any alternate to resolve this deficiency .

We have no predicate's dosimetric information . how can we compare this with our device?
 
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