Contraluz
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Good evening, folks. If the following has been discussed prior, please excuse. I do think, though, the issue is still current, even more so with the present "made in the US" thing...
So, while talking with a colleague about the hurdles of FDA regulations, the question came up about FDA approved materials and outsourcing to China. I am pretty sure the FDA does not have the authority to check labs abroad if they us materials, or not, that are FDA approved, for restorations sent to the US.
Now, my guess is that there is a loop hole and it is actually permitted to import dental prostheses, that are put into the Pt. mouth.
How does that compare to the hoops and loops a company has to jump trough, to get a material or device approved, they want to sell here, in the US? Every Car has to meat certain minimal criteria, imported or not, if it wants to be sold here in the US (That is the reason the US is missing out on some nice cars... ).
Any way, I would love to hear from you guys. Thanks in advance,
Michael
So, while talking with a colleague about the hurdles of FDA regulations, the question came up about FDA approved materials and outsourcing to China. I am pretty sure the FDA does not have the authority to check labs abroad if they us materials, or not, that are FDA approved, for restorations sent to the US.
Now, my guess is that there is a loop hole and it is actually permitted to import dental prostheses, that are put into the Pt. mouth.
How does that compare to the hoops and loops a company has to jump trough, to get a material or device approved, they want to sell here, in the US? Every Car has to meat certain minimal criteria, imported or not, if it wants to be sold here in the US (That is the reason the US is missing out on some nice cars... ).
Any way, I would love to hear from you guys. Thanks in advance,
Michael