Importing a general wellness low risk product

duinyk

Involved In Discussions
#1
Talking about the guidance document on General wellness low risk device. If I had to import such a device are there any guidance that will relate to these?
Also, if I classify the device as general wellness low risk device I understand FDA registration is not needed nor device listing right? Can someone please give a brief insight as to how this works? Thanks
 
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shimonv

Trusted Information Resource
#2
First you need to establish if this device is a medical device or general wellness device. There are laws (FFDCA and 21 Century Cures Act) and FDA guidances that explains that.
If your device is not a medical device, then all of the FDA regulations, including establishment registration and device listing do not apply to your device; it would not be under FDA jurisdiction.
However, depending on what the device consists of, some other regulations might be applicable. For example if this is a telecommunication device, then you might be required to follow the Federal Communications Commission (FCC) regulations.

You will need the assistance of an RA person unless the original equipment manufacturer can help you with both inquiries.

Good Luck,
Shimon
 

duinyk

Involved In Discussions
#3
If this device in question qualifies as a general wellness device, what will one need to show at the level of importation?
 

shimonv

Trusted Information Resource
#4
You would probably need to state that it is not a medical device. It's best to discuss this with your customs broker.
 
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