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esubmission

Question tag: esubmission 12 Questions

0 Votes 1 Ans

Should I set security settings or passwords on my PDF files that are attached to the questions in the eSubmission?

attached esubmission files passwords PDF security settings

0 Votes 1 Ans

Can an old eSubmission be reused to generate a new eSubmission by editing it to include the new information for a similar device?

device editing esubmission reused similar

0 Votes 1 Ans

What if I want to make a change to a file after it has been attached to a question in the eSubmission?

attached esubmission file

0 Votes 1 Ans

What do I do if I “package” the eSubmission and then decide to make a change?

decide esubmission package

0 Votes 1 Ans

What constitutes a complete 510(k) eSubmission to the Office of In Vitro Diagnostics (OIVD)?

COMPLETE constitutes Diagnostics esubmission Office OIVD Vitro

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?

admin CeSub esubmission esubmitter Reference section standard Tab

0 Votes 1 Ans

What if I do not find a relevant section or question for the information that I want to include in the eSubmission?

esubmission relevant section

0 Votes 1 Ans

How can I check to make sure that all the attached files in the eSubmission are included on the CD?

attached CD esubmission files included sure

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)?

CeSub esubmission esubmitter hardcopies OIVD Software submit

0 Votes 1 Ans

Once I package the completed eSubmission, what do I burn to the CD?

burn CD esubmission package

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)?

esubmission esubmitter fda hardcopies OIVD Software submit

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 FDA eSubmitter software database?

admin esubmission esubmitter fda Reference section standard Tab