Importing into US without 510K/FDA Clearance

neash83

Starting to get Involved
#1
Hello,

I am looking to get clarity on a question, which I suspect I know the answer to, but interested in wider views.

Is there any way to import a medical device into the US (from China) without 510k clearance? The specific context is that the device is currently under FDA review, so in theory will have it soon. However I'd like to understand if we can get it into the country prior to clearance, put it into a bonded warehouse (or the like) and then only start to distribute once we have the appropriate clearance.

Thanks
 
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QuickSpace

Starting to get Involved
#2
Hello,

I am looking to get clarity on a question, which I suspect I know the answer to, but interested in wider views.

Is there any way to import a medical device into the US (from China) without 510k clearance? The specific context is that the device is currently under FDA review, so in theory will have it soon. However I'd like to understand if we can get it into the country prior to clearance, put it into a bonded warehouse (or the like) and then only start to distribute once we have the appropriate clearance.

Thanks
No, You will not be able to do that, unless you have the 510k Clearance, registered your facility, and listed your device in the FDA Database.
 
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