Regulatory Open Forum

Hi Everybody,

Is there a way to show a class 2 device at a trade show that is currently in development but not yet submitted to the FDA?  The 510k won't be submitted until a month after the trade show but most development work is done.  We're a small company.  Any guidance is appeciated.  Thank you!

Anon,

Displaying, showing, and even some functionality of a Class II or Class III device at a trade show is acceptable ... within certain limits.  There is no specific regulation describing exactly what you can or can not display or show, but there is wording within 21 CFR 812, FD&C Act, and other guidance around labelling and advertising of investigational devices and unapproved devices.  Also keep in mind showing a device which has an existing IDE is also different from showing an unapproved device.

We commonly had signage or labels on the device stating clearly "Not for Sale in the United States" and/or "Not for Human Use".  The functionality of the device was always something tricky too with FDA as had comments over the years about devices at trade shows should be non-functional, i.e. having the power cord unplugged or battery out.  Also have to be very careful about stating or making claims for any unapproved device at a conference or trade show because they have not been evaluated by the FDA.

When you have submitted the 510(k) application, then usually the labelling can state, "510(k) Pending" and there is more advertising which can be done at that point to garner sales once the device is cleared (or approved for Class III); again a device under an existing IDE still has specific requirements for labelling.  And of course, FDA has provided some guidance over the years for Drug, Food, Devices, and Cosmetics in conjunction with the FTC about advertising and promotion which should be reviewed.  On a final note, it is known FDA personnel walk around conferences and Trade Shows so make sure if showing unapproved devices they are definitely clearly labelled and any advertising on the booth has been reviewed.

Hi Everybody,

Is there a way to show a class 2 device at a trade show that is currently in development but not yet submitted to the FDA?  The 510k won't be submitted until a month after the trade show but most development work is done.  We're a small company.  Any guidance is appeciated.  Thank you!