Importing a general wellness low risk product

duinyk

Involved In Discussions
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
 

shimonv

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

Haresh

Involved In Discussions
Hi Team
I'm associated with elsmar since 1 year and getting lot of information .Currently I have one question as below. It would be great if anyone help me to give answer on below question.
Suppose legal manufacturer based in US and having 510 K for instrument and this company wants to do manufacturing from non-US based company.But this non- US based company will do subcontracting for these instruments which will be manufactured and assembled by subcontractor.And non- US based company will only do inspection and will distribute the device to legal manufacturer based in USA.So, question is that whether subcontractors and non US based company needs establishment registration &device list or not? Or only required for subcontractors.
Awaiting your positive response
 
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