Question

Submitting Clinical data for labeling expansion

  • 31 October 2022
  • 6 replies
  • 51 views

Userlevel 1

Hello, 

I am looking into trying to expand our labeling to include some clinical trial results so we can use them in marketing material.  Is there a good guidance that explains the process for devices? Would I need to submit a full trial report for a labeling claim (rather than an efficacy claim)

I have found the guidance for Acceptance of Clinical Data to support submissions Q&A, but was not sure if there was something better. 

Thank you for your help,

Caitlin


6 replies

Userlevel 2
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Hi @caitlin what market approval does the device have? Your talking US FDA right?

 

 

Userlevel 1

We do already have approval using the 510(k) pathway. Since then, there have been several completed trials, the results of which we were hoping to using in our marketing materials. We are looking to submit a pre-sub soon, but was hoping to better understand before I ask dumb questions. 

 

 

Userlevel 2
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@caitlin I am afraid that my experience with the FDA to date does not allow me to provide you with a helpful answer.

But let me bring your question to a larger forum, anonymously, and see if we can get a response from there. I’ll be right back!

 

Userlevel 1

Thank you for asking around! Any help would be useful. 

Userlevel 2
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@caitlin sorry to say that I did not get any response back on this. Maybe there’s a LinkedIn group where this question could be addressed?

Userlevel 1

Thank you! If there is no obvious answer I am missing, that is ok.  I will see what they say and report back. 

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