Waiting for FDA clearance for your medical device can definitely feel like an eternity, but it’s important to be aware of what not to do during this process. An article
by Grey Matter Marketing lists out the many dos and don’ts when it comes to advertising and promoting your medical device during this waiting period.
A medical device is considered “investigational” when it does not yet have FDA clearance and cannot be advertised or have orders purchased for it. The FDA does, however, make a few exceptions when it comes to conferences and trade shows.
A company pending FDA approval can display or advertise their device at a trade show, but there a few things they should be aware of:
- You cannot solicit or accept purchase orders for your device.
- You cannot say it is safe and effective for investigational use.
- You cannot make claims that your product is safe, reliable, durable, or effective under investigation.
- The FDA frowns upon mass mailings for solicitation for clinical investigators.
If attending a trade show, it is also very important to display a sign stating your product is pending 510k clearance and is not available for sale.
It is critical to be aware of the above in regard to medical device advertising and promotion prior to FDA clearance.