FDA De Novo Cover Letter - What is expected

#1
We have designed our first product and have been granted breakthrough by FDA. The application will be De Novo, and wondering if anyone has a sample of what the FDA is looking for with regards to a Cover Letter. This will be my first De Novo application. There is guidance for what to include in all other areas, but nothing for what should be included in the cover letter. Thanks in advance.
 
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primavesvera

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#3
We have designed our first product and have been granted breakthrough by FDA. The application will be De Novo, and wondering if anyone has a sample of what the FDA is looking for with regards to a Cover Letter. This will be my first De Novo application. There is guidance for what to include in all other areas, but nothing for what should be included in the cover letter. Thanks in advance.
A couple of years ago we submitted a De Novo and the Cover letter format was similar to our 510(k) Cover Letter and we didn't have any problem. What I am trying to say - try looking here, under the section Cover Letter and adapt to your situation in De Novo context: Content of a 510(k)

And, best of luck with the submission!
 

Watchcat

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#4
De novo is my baby. :bighug:

Note that for the 510(k), the information listed is to be included in the cover letter if you don't use the Premarket Submission Cover Sheet (Form 3514). I have always used Form 3514, so my cover letters have always been pretty brief.

One problem with the De novo is that it is still new, and not yet stable. In the draft Proposed Rule, the only reference to the inclusion of a cover letter is for CBER De novos, not CDRH De novos.

I personally don't think FDA ever looks for much of anything in a cover letter. What it looks for is the information it needs, wherever it may find it. On your end, you want it to be easy to find. I think it is easier for FDA to find information in its own familiar form than in a cover letter.
 
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