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Re: Probity post# 330517

Tuesday, 07/02/2024 10:38:52 PM

Tuesday, July 02, 2024 10:38:52 PM

Post# of 330785
A different approach:

Here’s a hypothetical. What if BIEL decided to change manufacturers. Maybe make the device here in the states for example.

Now the new manufacturer would need to be registered with and inspected by the FDA.

Ok, so what would BIEL have to do in order to sell the devices made at the new facility?

That’s essentially all that the new company would have to do as well, if they are going to sell the exact same device.