FDA Pre-Submission Meeting Advice

Dobby1979

Involved In Discussions
Hi All.

Happy New Year! When should we stop saying that? Maybe that is a question I could ask in my pre-sub!

The regulatory arena has always played second fiddle to Quality over my years in the industry but now I have the responsibility of getting approval for our new product!

I want to have a pre-sub meeting with the FDA so am looking at the FDA's CDRH 3514 form and also the guidance on what is required. Does anyone have any redacted templates that I could take a look at? It would be great to see what is required and the level of detail that is required for the application for a meeting.

Are there any housekeeping activities that I should have completed thus far, any fees that have to be paid? We have not yet registered with the FDA so I guess this should be one of the first things that we do?

Thanks for any help / advice
 
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