Is it legal to attend a trade show while you have a 510(k) application pending?

rwend07

Involved In Discussions
I found another thread somewhat addressing this issue but it seemed to be in the wrong spot, so I am copying my question here to maybe get more applicable responses.

Going back to the trade show discussion, is it legal to attend a trade show while you have a 510(k) application pending within the US if you make it clear on any banners/materials that the device is pre-regulatory/not for human use and that you are in no way preparing to take orders on the device? I haven't seen anything that would make me think there is any regulation strictly prohibiting this, but it seems to be a gray area in a lot of what I have seen.

Secondly, can you take contacts from medical professionals at conference if you again make it clear that the device is not to market? If not, how would you be able to set up an IDE nationwide trial without making these kinds of connections?

It would be great if someone could point me in the direction of anything that makes this issue a bit more clear. Thanks for the help!
 
Top Bottom