Hi Anon,
This link (though not sure I'd take it as actual legal advice) might be helpful.
https://www.greymattermarketing.com/blog/promoting-medical-devices-prior-to-fda-approval-or-clearance
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Kristina Cook
San Francisco CA
United States
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Original Message:
Sent: 19-May-2020 14:03
From: Anonymous Member
Subject: pre-market demos
This message was posted by a user wishing to remain anonymous
Hi all,
I am trying to understand where is the line between promotion of unapproved devices and raising awareness about the existence of a device that will be commercialized only after clearance/approval.
Are activities like demos at the client premises or trade shows ok, if the device is accompanied by correct disclaimers "Caution: Investigational Device. Limited by Federal (or United States) Law to Investigational Use" or "not available for sale in the USA" and the company keeps off topics like pricing, claims, promises of safety and effectiveness, clearance/approval etc.?
What is the best practice to have some initial (and lawful!) visibility and get feedback about market needs?
Thanks