Scientific and Research Papers for Foreign Approved Devices

fialor

Involved In Discussions
Hi All,

Could anyone help please.

I am looking for guidance on what can be shared at an exhibition including web publication for medical devices with foreign approval which are not manufactured in the USA.

I have found a guidance on devices approved but with new uses but this is silent on the question above.

Thanks for your help.

Fialor
 

shimonv

Trusted Information Resource
Hi Fialor,
You are asking a very broad question and therefore I can only offer a broad answer:
- Check the content for any false or misleading claims.
- Beware not promote any off-label use.
- I would avoid web publication because their credibility is doubtful.
- You may want to put a stamp on the printed material stating that the device / indications is not approved in the local market.


Good luck,
Shimon
 
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