Exporting Demo Medical Devices from USA

#1
Elsmar Family...

My place of work just released their first medical device in the US. Is it a Class I device that provides for refractive (vision) correction when interfacing with a general computing platform. The general computing platform provides the experience, yet vision correction is necessary. The general computing platform is not a medical device and is approved, via other regulatory agencies, in most countries worldwide.

Now the organization wants to build and send demo kits, containing varied refractive correction devices, to several OUS countries in order to share the experience provided via the general computing platform with potential consumers. The refractive correction device, will be permanently marked with 'demo only'

Help would be appreciated to better understand the requirements on demo units/kits as there does not appear to be much via the regulations.
Is it acceptable to interpret the regulations and determine the refractive device to NOT be a medical device following 'demo only' marking? I can make an argument that marking them 'demo only' changes their intended use thereby making them not fit the definition of a medical device (per FDA).

Thoughts and insights much appreciated..
 
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shimonv

Trusted Information Resource
#2
You are correct in your assumption that once you mark the device as "demo only" or "not for human use" it no longer meets the definition of a medical device. But keep in mind that with some OUS countries there are additional requirements to pass through the customs.
Your contacts in each of these countries can help you with the specifics.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
once you mark the device as "demo only" or "not for human use" it no longer meets the definition of a medical device.
I tend to agree about "not for human use", but "demo only" is a bit more vague and I have a hunch that FDA won't accept the same approach to it so easily.
 
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