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ESUBMITTER HELPS 510(k) APPLICANTS WITH “QUIK” REVIEW

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For device manufacturers using the "Quik" Review process, the FDA has released some software, called eSubmitter, that helps them fill out the application electronically and eliminates the need for paper copies altogether.

The software uses Java to make it more cross-platform and is designed in “1990s Industrial” style…

 

fda-esubmitter-new-600

 

…but who cares? The tool helps companies fill in the extensive paperwork and that’s all that matters. The sections of a submission are shown in the tool:

 

fda-esubmitter-info-600

 

This tool can even help companies not submitting in the “Quik” Review pilot by showing them all the information needed. However, they can’t use the output directly through the tool, they still need to submit in the traditional way.

 

FDA.gov

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