We'd need a little more info to give a better answer, but 21 CFR 812.7 (cannot promote IDE) and an old FDA guidance or two are all you have, with the gist of it being that you cannot commercialize, promote, or make claims about an unapproved/uncleared device.
While you can find a few devices demoed in actual use at a trade show (e.g., TENS or Ultrasound), you'd have to be comfortable that you are demonstrating technical and design features under development with appropriate signage (Investigational Device, not for sale, etc). The rules of the trade show operator may also prohibit things that are allowed elsewhere.
Some companies are very conservative, and they won't even display a device unless it's 510(k) pending, while smaller companies often take more risk because it's a trade show and everyone goes there to see what's in the pipeline.
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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.lawMobile: 847-421-8361
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Original Message:
Sent: 06-Apr-2018 13:51
From: Anonymous Member
Subject: Advertising/Promotion of Unapproved Device at Trade Show
This message was posted by a user wishing to remain anonymous
My company mfrs a device that is not yet approved in the US. In preparation for a trade show this summer, I have provided guidance on labeling requirements as well as what can be said about the device (e.g. intended use/Indications etc). There will be videos demonstrating how the device works/is used.
The device is an electro-mechanical medical device worn externally and used in the home. I have been asked two questions about the trade show:
1) Can the device be demonstrated on visitors to the booth? My answer is a definite "no".
2) Can an employee of the company demo the device to visitors that come to the booth? Note: this would require the device to be operational.
For some reason, I am having a little more difficulty with this second question and would appreciate feedback from the forum.
Thanks