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Writing a presubmission to the FDA prior to the De novo submission

#1
Hello everyone,

I hope you are doing well.
Does anyone have experience of writing a presubmission to the FDA prior to the De novo submission? Is there a template or format that I can follow? What needs to be included in the cover letter?

Thanking you in advance!!!!
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
Q-Submission Guidance - Level 1 Update (fda.gov)

I have only been part of a few pre subs. In general, you will need to propose the path forward to FDA and align your expectations with theirs. This is to prevent months of work and ending up at the wrong finish line. They will expect you to take notes and after the meeting submit them to FDA for review. They should correct any errors in expectations.
 
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