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
I received an anonymous question and wondered if I could get some help! If I have a device currently marketed in the US and I want to start marketing in the EU, is clinical evidence that comes only from the US acceptable for notified bodies or does clinical evidence also need to include EU and/or other parts of the world?@joningib @Keith Kallmes @BenB are you able to help?
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