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esubmitter

Question tag: esubmitter 26 Questions

0 Votes 1 Ans

Whose name and mailing address appears on the Submittal Letter generated by the CeSub eSubmitter?

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0 Votes 1 Ans

Can I cut and paste text into the text boxes in the CeSub eSubmitter software?

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0 Votes 1 Ans

How can I include information on the Secondary Contact in the Submittal Letter generated by the CeSub eSubmitter?

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0 Votes 1 Ans

Where can I find more information on the appropriate and efficient use of the CeSub eSubmitter software (i.e. User Manual, etc)?

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0 Votes 1 Ans

How should I answer the questions with the optional file attachment in the CeSub eSubmitter application?

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0 Votes 1 Ans

I installed eSubmitter on an earlier version of Windows and I have since upgraded to Windows Vista. What are my potential issues?

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0 Votes 1 Ans

What if the standard I want to reference in the eSubmission (section 7.0 of the Admin tab) is not listed in the CeSub eSubmitter software database?

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0 Votes 1 Ans

When I submit a 510(k) eSubmission for OIVD using the CeSub eSubmitter software, do I need to include hardcopies of the 510(k)?

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0 Votes 1 Ans

How do I “Bundle” 510(k) submissions using the CeSub eSubmitter software?

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0 Votes 1 Ans

Is the CeSub eSubmitter software Part 11 Compliant?

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0 Votes 1 Ans

What are the known compatibility issues with FDA eSubmitter running on a Windows Vista operating system?

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0 Votes 1 Ans

I am planning to install FDA eSubmitter on Windows Vista. How do I proceed?

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0 Votes 1 Ans

Where can I find more information on the appropriate and efficient use of the FDA eSubmitter software (i.e. User Manual, etc)?

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0 Votes 1 Ans

Whose name and mailing address appears on the Submittal Letter generated by the FDA eSubmitter?

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0 Votes 1 Ans

How can I include information on the Secondary Contact in the Submittal Letter generated by the FDA eSubmitter?

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0 Votes 1 Ans

How should I answer the questions with the optional file attachment in the FDA eSubmitter application?

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0 Votes 1 Ans

Is the FDA eSubmitter software Part 11 Compliant?

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0 Votes 1 Ans

I installed FDA eSubmitter on an earlier version of Windows and I have since upgraded to Windows Vista. What are my potential issues?

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0 Votes 1 Ans

Can I cut and paste text into the text boxes in the FDA eSubmitter software?

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0 Votes 1 Ans

When I submit a 510(k) eSubmission for OIVD using the FDA eSubmitter software, do I need to include hardcopies of the 510(k)?

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