Monday, March 07, 2011 11:32:57 AM
As a reminder, if you missed the post earlier today as well as weeks ago, the FDA replied (in this post):
Only items currently undergoing 510(k) review can be demonstrated or marketed. No promotion or advertising activities can be performed before the device has been cleared for marketing. Demonstrations of the device on television, video, the internet, or any other medium are considered to be marketing. The same is true of still print displays and other information about the device that is made available to the public.
You can have a display unit to show the shareholders. The display unit must be clearly marked with “For display purposes only” and “Not for human use.”
Keeping it real.
Homer
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