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