Promoting and marketing of a non approved device

Jkc3usc12

Involved In Discussions
#1
I am looking for some guidance on the ability to promote or market a medical devices that have not been approved. These devices are still in the development stage and hoping to be a new product launched in time.

For example without making claims, no names of the product, can my company make vague statements about coming soon a new leading device in the future?

I have looked for guidance on that and would appreciate and help.
 
Elsmar Forum Sponsor

Gisly

Starting to get Involved
#2
Seen all big MEDTEC companies doing this at conference floors; Siemens, GE etc... with a sign saying product under development, not cleared for (...) bla bla...
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
Any device not cleared by FDA is Investigational.
There are exemptions for Trade Shows:
Cant offer pricing or accept POs unless it's for investigational purpose
Cant list that the product is safe, effective, reliable or durable.
Cant compare it to competitors product(s)

My understanding is, generally, FDA does not allow you to promote an unapproved device in such a way as a user would alter their healthcare treatment. FDA has made finding against companies who market their devices prior to approval. If the device is very low risk, like a bandage, just listing with the FDA may be enough.


FDA Regulation of Medical Devices (fas.org)
 

Jkc3usc12

Involved In Discussions
#5
Any device not cleared by FDA is Investigational.
There are exemptions for Trade Shows:
Cant offer pricing or accept POs unless it's for investigational purpose
Cant list that the product is safe, effective, reliable or durable.
Cant compare it to competitors product(s)

My understanding is, generally, FDA does not allow you to promote an unapproved device in such a way as a user would alter their healthcare treatment. FDA has made finding against companies who market their devices prior to approval. If the device is very low risk, like a bandage, just listing with the FDA may be enough.


FDA Regulation of Medical Devices (fas.org)
Do you know where this is stated in the regulation or where it came from?
 
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